K924101 is an FDA 510(k) clearance for the STERILE CONVERTORS SMS POLYPROPYLENE GOWN & DRAPE. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Baxter Healthcare Corp (Waukegan, US). The FDA issued a Cleared decision on April 11, 1994, 606 days after receiving the submission on August 13, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K924101 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 13, 1992 |
| Decision Date | April 11, 1994 |
| Days to Decision | 606 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 |