The following data is part of a premarket notification filed by Derivados De Gasa, S.a. De C.v. with the FDA for Protec Gauze Sponge.
Device ID | K955321 |
510k Number | K955321 |
Device Name: | PROTEC GAUZE SPONGE |
Classification | Gauze/sponge, Internal |
Applicant | DERIVADOS DE GASA, S.A. DE C.V. 1247 FLORIDA AVE. Palm Harbor, FL 34683 |
Contact | Patrick J Lamb |
Correspondent | Patrick J Lamb DERIVADOS DE GASA, S.A. DE C.V. 1247 FLORIDA AVE. Palm Harbor, FL 34683 |
Product Code | EFQ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-11-20 |
Decision Date | 1995-12-19 |