K760997 is an FDA 510(k) clearance for the UNDER BOTTOCKS DRAPE. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 23, 1977, 135 days after receiving the submission on November 8, 1976.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K760997 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 1976 |
| Decision Date | March 23, 1977 |
| Days to Decision | 135 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 |