Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K161421 |
FOIA Releasable 510(k) |
K161421
|
Device Name |
Single Use Surgical Suction Irrigator |
Applicant |
JIANGSU HAIZE MEDICAL SCIENTIFIC DEVELOPMENT CO.,LTD. |
NO.99, FURONGZHONGSAN RD, XISHAN ECONOMICAL DEVELOPMENT ZONE |
WUXI,
CN
214000
|
|
Applicant Contact |
Vivian Sun |
Correspondent |
JIANGSU HAIZE MEDICAL SCIENTIFIC DEVELOPMENT CO.,LTD. |
NO.99, FURONGZHONGSAN RD, XISHAN ECONOMICAL DEVELOPMENT ZONE |
WUXI,
CN
214000
|
|
Correspondent Contact |
Vivian Sun |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 05/23/2016 |
Decision Date | 06/24/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|