K071459 is an FDA 510(k) clearance for the B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on August 16, 2007, 83 days after receiving the submission on May 25, 2007.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K071459 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 25, 2007 |
| Decision Date | August 16, 2007 |
| Days to Decision | 83 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 |