The following data is part of a premarket notification filed by Look, Inc. with the FDA for Sterile Black Monofilament Nylon Non-absor. Suture.
| Device ID | K903029 |
| 510k Number | K903029 |
| Device Name: | STERILE BLACK MONOFILAMENT NYLON NON-ABSOR. SUTURE |
| Classification | Suture, Nonabsorbable, Synthetic, Polyamide |
| Applicant | LOOK, INC. WASHINGTON SQUARE 1050 CONNECTICUT AVENUE N.W. Washington, DC 20036 |
| Contact | John M Packman |
| Correspondent | John M Packman LOOK, INC. WASHINGTON SQUARE 1050 CONNECTICUT AVENUE N.W. Washington, DC 20036 |
| Product Code | GAR |
| CFR Regulation Number | 878.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-10 |
| Decision Date | 1990-10-25 |