|
Device |
syringe, antistick |
Product Code | MEG |
Regulation Number |
880.5860
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANHUI TIANKANG MEDICAL PRODUCTS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANHUI TIANKANG MEDICAL TECHNOLOGY CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BERPU MEDICAL TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BERPU MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDINAL HEALTH 200, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GEMTIER MEDICAL (SHANGHAI) INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GLOBAL MEDI PRODUCTS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANGDONG HAIOU MEDICAL APPARATUS STOCK CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANGDONG INTMED MEDICAL APPLIANCE CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HENAN NURSECARE BIOTECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INVIRO MEDICAL DEVICES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
JEESUNG MEDICAL CO LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JEESUNG MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGSU CAINA MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
JIANGSU CAINA MEDICAL CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGSU KANGBAO MEDICAL EQUIPMENT CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGSU KANGBAO MEDICAL EQUIPMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGSU MICSAFE MEDICAL TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGSU MICSAFE MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGSU YILE MEDICAL ARTICLE CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGXI HONGDA MEDICAL EQUIPMENT GROUP LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDICALCHAIN INTL. CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDLINE INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
1. K101560 MEDLINE RETRACTABLE SAFETY SYRINGE
|
MEDLINE INDUSTRIES, LP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEMERA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
REXAM CONSUMMER PLASTICS INC.D/B/A REXAM PHARMA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
REXAM HEALTHCARE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
REXAM PHARMA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RONCADELLE OPERATIONS SRL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SAFETY SYRINGES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SANG-A FRONTEC CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANTOU WEALY MEDICAL INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHANTOU WEALY MEDICAL INSTRUMENT CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANTOU WEALY MEDICAL INSTRUMENT CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHINA MED CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHINVA ANDE HEALTHCARE APPARATUS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SICHUAN PRIUS BIOTECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SINCERE MEDICAL DEVICE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SOL-MILLENNIUM MEDICAL, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOL-MILLENNIUM MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STA-MED, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SUNWELL BIOTECH CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUZHOU SAVICRED BIOTECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
U&U MEDICAL TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ULTI-MED INTL., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ULTIMED INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UNILIFE MEDICAL SOLUTIONS LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VAULT PARAGON GROUP, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WEST PHARMACEUTICAL SERVICES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WEST PHARMACEUTICAL SERVICES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
YANGZHOU MEDLINE INDUSTRY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHEJIANG KANGKANG MEDICAL-DEVICES CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHEJIANG LINGYANG MEDICAL APPARATUS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHUHAI DR MEDICAL INSTRUMENTS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|