K041846 is an FDA 510(k) clearance for the SABRESOURCE DRAPE. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Minrad, Inc. (Buffalo, US). The FDA issued a Cleared decision on August 26, 2004, 49 days after receiving the submission on July 8, 2004.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K041846 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 08, 2004 |
| Decision Date | August 26, 2004 |
| Days to Decision | 49 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 |