K944953 is an FDA 510(k) clearance for the OREX MEDICAL BEDDING. This device is classified as a Bedding, Disposable, Medical (Class I - General Controls, product code KME).
Submitted by Thantex Specialties, Inc. (Herndon, US). The FDA issued a Cleared decision on December 2, 1994, 56 days after receiving the submission on October 7, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6060.
| 510(k) Number | K944953 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 1994 |
| Decision Date | December 02, 1994 |
| Days to Decision | 56 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 |