K915649 is an FDA 510(k) clearance for the BARD 500ML RESERVOIR HOLDER. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by C.R. Bard, Inc. (North Reading, US). The FDA issued a Cleared decision on March 7, 1994, 810 days after receiving the submission on December 18, 1991.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K915649 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 18, 1991 |
| Decision Date | March 07, 1994 |
| Days to Decision | 810 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRN — Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |