The following data is part of a premarket notification filed by Derivados De Gasa, S.a. De C.v. with the FDA for Protec X-ray Detectable Gauze Sponge.
| Device ID | K955322 |
| 510k Number | K955322 |
| Device Name: | PROTEC X-RAY DETECTABLE GAUZE SPONGE |
| Classification | Gauze/sponge, Internal, X-ray Detectable |
| 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 | GDY |
| CFR Regulation Number | 878.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-20 |
| Decision Date | 1995-12-19 |