K946015 is an FDA 510(k) clearance for the IVALON EXTERNAL SPONGE. This device is classified as a Gauze / Sponge,nonresorbable For External Use (Class I - General Controls, product code NAB).
Submitted by Ivalon (San Diego, US). The FDA issued a Cleared decision on February 27, 1995, 80 days after receiving the submission on December 9, 1994.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4014.
| 510(k) Number | K946015 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 1994 |
| Decision Date | February 27, 1995 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | NAB — Gauze / Sponge,nonresorbable For External Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4014 |