K052773 is an FDA 510(k) clearance for the B. BRAUN 0.2 MICRON FILTER. 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 January 24, 2006, 113 days after receiving the submission on October 3, 2005.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K052773 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 2005 |
| Decision Date | January 24, 2006 |
| Days to Decision | 113 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 |