Device Classification Name |
Suture, Nonabsorbable, Silk
|
510(k) Number |
K012124 |
Device Name |
MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP |
Applicant |
JOHNSON & JOHNSON MEDICAL (CHINA) LTD. |
#75 NAN GU ZHI ROAD |
MONHANG, SHANGHAI,
CN
200245
|
|
Applicant Contact |
BEN TANG |
Correspondent |
JOHNSON & JOHNSON MEDICAL (CHINA) LTD. |
#75 NAN GU ZHI ROAD |
MONHANG, SHANGHAI,
CN
200245
|
|
Correspondent Contact |
BEN TANG |
Regulation Number | 878.5030
|
Classification Product Code |
|
Date Received | 07/06/2001 |
Decision Date | 09/19/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|