Device Classification Name |
wrap, sterilization
|
510(k) Number |
K071886 |
Device Name |
SELF SEAL STERILIZATION POUCH |
Applicant |
SHANGHAI JIANZHONG MEDICAL PACKAGING CO., LTD. |
1558-1-2101 SOUTH XIZANG ROAD |
SHANGHAI,
CN
200011
|
|
Applicant Contact |
LONGFU SONG |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
DANIEL W LEHTONEN |
Regulation Number | 880.6850
|
Classification Product Code |
|
Date Received | 07/09/2007 |
Decision Date | 12/27/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|