K913506 is an FDA 510(k) clearance for the CONVERTORS SAFECARE GOWN & DRAPE MATERIAL. 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 October 11, 1991, 65 days after receiving the submission on August 7, 1991.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K913506 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 1991 |
| Decision Date | October 11, 1991 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | KKX — Drape, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |