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 |