K811996 is an FDA 510(k) clearance for the GATOR DRAPES. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by The Anspach Effort, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 13, 1981, 29 days after receiving the submission on July 15, 1981.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K811996 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 1981 |
| Decision Date | August 13, 1981 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | KKX — Drape, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |