K915358 is an FDA 510(k) clearance for the PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH. This device is classified as a Tape And Bandage, Adhesive (Class I - General Controls, product code KGX).
Submitted by Medtronic Vascular (Brooklyn Center, US). The FDA issued a Cleared decision on April 28, 1992, 153 days after receiving the submission on November 27, 1991.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5240.
| 510(k) Number | K915358 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 27, 1991 |
| Decision Date | April 28, 1992 |
| Days to Decision | 153 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KGX — Tape And Bandage, Adhesive |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5240 |