K760357 is an FDA 510(k) clearance for the SKIN CLIP SYSTEM, DISPOSABLE (AVLOX ICI). This device is classified as a Apparatus, Air Handling, Bench (Class II - Special Controls, product code FZG).
Submitted by V. Mueller O.V. Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on October 27, 1976, 86 days after receiving the submission on August 2, 1976.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5070.
| 510(k) Number | K760357 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 1976 |
| Decision Date | October 27, 1976 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FZG — Apparatus, Air Handling, Bench |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5070 |