K944198 is an FDA 510(k) clearance for the SURGICAL MICROSCOPE DRAPE. This device is classified as a Cover, Barrier, Protective (Class II - Special Controls, product code MMP).
Submitted by Hydro-Med Products, Inc. (Dallas, US). The FDA issued a Cleared decision on November 27, 1994, 90 days after receiving the submission on August 29, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K944198 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 1994 |
| Decision Date | November 27, 1994 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MMP — Cover, Barrier, Protective |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |