K061615 is an FDA 510(k) clearance for the INTERDRY TEXTILE WITH SILVER. This device is classified as a Fiber, Medical, Absorbent (Class I - General Controls, product code FRL).
Submitted by Milliken Chemical (North Attleboro, US). The FDA issued a Cleared decision on December 22, 2006, 196 days after receiving the submission on June 9, 2006.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5300.
| 510(k) Number | K061615 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 2006 |
| Decision Date | December 22, 2006 |
| Days to Decision | 196 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRL — Fiber, Medical, Absorbent |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5300 |