K072654 is an FDA 510(k) clearance for the PATIENT SAFE SYRINGE. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Retractable Technologies, Inc. (Little Elm, US). The FDA issued a Cleared decision on December 14, 2007, 85 days after receiving the submission on September 20, 2007.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K072654 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 2007 |
| Decision Date | December 14, 2007 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF - Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |