K901629 is an FDA 510(k) clearance for the CHEM-SLEEVE. 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 April 27, 1990, 28 days after receiving the submission on March 30, 1990.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6060.
| 510(k) Number | K901629 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 1990 |
| Decision Date | April 27, 1990 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | KME — Bedding, Disposable, Medical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6060 |