K811717 is an FDA 510(k) clearance for the GATOR DRAPES. This device is classified as a Camera, Surgical And Accessories (Class I - General Controls, product code KQM).
Submitted by The Anspach Effort, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 20, 1981, 32 days after receiving the submission on June 18, 1981.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4160.
| 510(k) Number | K811717 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 18, 1981 |
| Decision Date | July 20, 1981 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | KQM — Camera, Surgical And Accessories |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4160 |