K093658 is an FDA 510(k) clearance for the RENU MEDICAL VASOPRESS CALF , THIGH GARMENTS- ALL SIZESD, RENU MEDICAL VASOPRESS FOOT GARMENTS. This device is classified as a Sleeve, Limb, Compressible (Class II - Special Controls, product code JOW).
Submitted by Renu Medical, Inc. (Everett, US). The FDA issued a Cleared decision on January 14, 2010, 50 days after receiving the submission on November 25, 2009.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5800.
| 510(k) Number | K093658 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 25, 2009 |
| Decision Date | January 14, 2010 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | JOW - Sleeve, Limb, Compressible |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5800 |