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 |