Device Classification Name |
wrap, sterilization
|
510(k) Number |
K112591 |
Device Name |
SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORS |
Applicant |
SAFE SECURE PACKAGING CO., LTD |
CHENGGUANG INDUSTRIAL PARK, |
NO.4 KUKENG PO NEW VILLAGE |
SHENZHEN, GUANGDON,
CN
5181100
|
|
Applicant Contact |
GARFIELD WANG |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
PAULA WILKERSON |
Regulation Number | 880.6850
|
Classification Product Code |
|
Date Received | 09/07/2011 |
Decision Date | 02/07/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|