K971597 is an FDA 510(k) clearance for the COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903). This device is classified as a Dressing, Wound, Hydrogel Without Drug And/or Biologic (Class I - General Controls, product code NAE).
Submitted by Coloplast Corp. (Fort Worth, US). The FDA issued a Cleared decision on July 29, 1997, 89 days after receiving the submission on May 1, 1997.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4022.
| 510(k) Number | K971597 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 1997 |
| Decision Date | July 29, 1997 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NAE — Dressing, Wound, Hydrogel Without Drug And/or Biologic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4022 |