K910657 is an FDA 510(k) clearance for the QUALTEX ISLAND DRESSING. This device is classified as a Tape And Bandage, Adhesive (Class I - General Controls, product code KGX).
Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on July 1, 1991, 137 days after receiving the submission on February 14, 1991.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5240.
| 510(k) Number | K910657 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 1991 |
| Decision Date | July 01, 1991 |
| Days to Decision | 137 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | KGX — Tape And Bandage, Adhesive |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5240 |