K973146 is an FDA 510(k) clearance for the MENTOR SUPER ABSORBENT DRAPE. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Mentor Ophthalmics, Inc. (Santa Barbara, US). The FDA issued a Cleared decision on December 4, 1997, 104 days after receiving the submission on August 22, 1997.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K973146 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 1997 |
| Decision Date | December 04, 1997 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KKX — Drape, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |