Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polyamide
|
510(k) Number |
K903029 |
Device Name |
STERILE BLACK MONOFILAMENT NYLON NON-ABSOR. SUTURE |
Applicant |
LOOK, INC. |
WASHINGTON SQUARE |
1050 CONNECTICUT AVENUE N.W. |
WASHINGTON,
DC
20036
|
|
Applicant Contact |
JOHN M PACKMAN |
Correspondent |
LOOK, INC. |
WASHINGTON SQUARE |
1050 CONNECTICUT AVENUE N.W. |
WASHINGTON,
DC
20036
|
|
Correspondent Contact |
JOHN M PACKMAN |
Regulation Number | 878.5020
|
Classification Product Code |
|
Date Received | 07/10/1990 |
Decision Date | 10/25/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|