K952918 is an FDA 510(k) clearance for the PTFE SYRINGE FILTER. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by B.Braun Medical, Inc. (So. San Francisco, US). The FDA issued a Cleared decision on September 15, 1995, 81 days after receiving the submission on June 26, 1995.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K952918 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 1995 |
| Decision Date | September 15, 1995 |
| Days to Decision | 81 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 |