K903358 is an FDA 510(k) clearance for the ADVANCE LAPAROTOMY SPONGE, LAP SPONGE. This device is classified as a Gauze/sponge, Internal, X-ray Detectable (Class I - General Controls, product code GDY).
Submitted by Advance Medical Designs, Inc. (Marietta, US). The FDA issued a Cleared decision on November 29, 1990, 126 days after receiving the submission on July 26, 1990.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4450.
| 510(k) Number | K903358 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 1990 |
| Decision Date | November 29, 1990 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GDY — Gauze/sponge, Internal, X-ray Detectable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4450 |