K042164 is an FDA 510(k) clearance for the SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE). This device is classified as a Dressing, Wound, Drug.
Submitted by Medline Industries, Inc. (Portland, US). The FDA issued a Cleared decision on June 9, 2005, 302 days after receiving the submission on August 11, 2004.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K042164 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 2004 |
| Decision Date | June 09, 2005 |
| Days to Decision | 302 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |