K151249 is an FDA 510(k) clearance for the PUREWAY SHARPS COLLECTOR 1.2 GALLON, PUREWAY SHARPS COLLECTOR 2 GALLON, PUREWAY SHARPS COLLECTOR 3 GALLON. This device is classified as a Container, Sharps (Class II - Special Controls, product code MMK).
Submitted by Pureway Compliance, Inc. (Santa Monica, US). The FDA issued a Cleared decision on September 4, 2015, 115 days after receiving the submission on May 12, 2015.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K151249 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 2015 |
| Decision Date | September 04, 2015 |
| Days to Decision | 115 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MMK - Container, Sharps |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |