K931267 is an FDA 510(k) clearance for the CONVERTORS ISO BAC 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 November 7, 1994, 609 days after receiving the submission on March 8, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K931267 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 1993 |
| Decision Date | November 07, 1994 |
| Days to Decision | 609 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 |