K110276 is an FDA 510(k) clearance for the POWERPRESS UNIT. This device is classified as a Sleeve, Limb, Compressible (Class II - Special Controls, product code JOW).
Submitted by Hanuri Distribution, Inc. (Chatsworth, US). The FDA issued a Cleared decision on November 9, 2011, 282 days after receiving the submission on January 31, 2011.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5800.
| 510(k) Number | K110276 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 2011 |
| Decision Date | November 09, 2011 |
| Days to Decision | 282 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 |