K970736 is an FDA 510(k) clearance for the BRAUN PREFILLED SYRINGE. This device is classified as a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II - Special Controls, product code FOZ).
Submitted by B.Braun Medical, Inc. (Bethlehem, US). The FDA issued a Cleared decision on December 16, 1998, 656 days after receiving the submission on February 28, 1997.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K970736 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 1997 |
| Decision Date | December 16, 1998 |
| Days to Decision | 656 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5200 |