K110715 is an FDA 510(k) clearance for the INTERDRY SILVER. This device is classified as a Fiber, Medical, Absorbent (Class I - General Controls, product code FRL).
Submitted by Milliken Healthcare Products, LLC (Spartanburg, US). The FDA issued a Cleared decision on November 4, 2011, 234 days after receiving the submission on March 15, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5300.
| 510(k) Number | K110715 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 15, 2011 |
| Decision Date | November 04, 2011 |
| Days to Decision | 234 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 |