The following data is part of a premarket notification filed by Look, Inc. with the FDA for Gut Sutures.
| Device ID | K896554 |
| 510k Number | K896554 |
| Device Name: | GUT SUTURES |
| Classification | Suture, Absorbable, Natural |
| 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 | GAL |
| CFR Regulation Number | 878.4830 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-17 |
| Decision Date | 1990-05-31 |