K885143 is an FDA 510(k) clearance for the ABSORBENT GAUZE ROLL. This device is classified as a Gauze/sponge, Internal.
Submitted by Smith & Nephew, Inc. (Miami, US). The FDA issued a Cleared decision on February 10, 1989, 57 days after receiving the submission on December 15, 1988.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K885143 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 1988 |
| Decision Date | February 10, 1989 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | EFQ — Gauze/sponge, Internal |
| Device Class | — |