K932539 is an FDA 510(k) clearance for the DOCTOR DOWN --RESCUE WRAP. This device is classified as a Bedding, Disposable, Medical (Class I - General Controls, product code KME).
Submitted by Three Dog Down (Cincinnati, US). The FDA issued a Cleared decision on November 2, 1993, 160 days after receiving the submission on May 26, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6060.
| 510(k) Number | K932539 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 1993 |
| Decision Date | November 02, 1993 |
| Days to Decision | 160 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 |