K931610 is an FDA 510(k) clearance for the OMNISORB II, NONWOVEN SPONGE, STERILE AND NON. This device is classified as a Gauze / Sponge,nonresorbable For External Use (Class I - General Controls, product code NAB).
Submitted by Omni Mfg., Inc. (Eaton Park, US). The FDA issued a Cleared decision on June 24, 1993, 84 days after receiving the submission on April 1, 1993.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4014.
| 510(k) Number | K931610 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 1993 |
| Decision Date | June 24, 1993 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NAB — Gauze / Sponge,nonresorbable For External Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4014 |