K071552 is an FDA 510(k) clearance for the PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING. This device is classified as a Dressing, Wound, Drug.
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on April 25, 2008, 324 days after receiving the submission on June 6, 2007.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K071552 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 06, 2007 |
| Decision Date | April 25, 2008 |
| Days to Decision | 324 days |
| Submission Type | Abbreviated |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |