K912257 is an FDA 510(k) clearance for the CHEM-SLEEVE B. This device is classified as a Bedding, Disposable, Medical (Class I - General Controls, product code KME).
Submitted by Haz-Med, Inc. (Holland, US). The FDA issued a Cleared decision on December 31, 1991, 223 days after receiving the submission on May 22, 1991.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6060.
| 510(k) Number | K912257 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 1991 |
| Decision Date | December 31, 1991 |
| Days to Decision | 223 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | KME — Bedding, Disposable, Medical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6060 |