K913718 is an FDA 510(k) clearance for the PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 30, 1991, 90 days after receiving the submission on August 1, 1991.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K913718 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 1991 |
| Decision Date | October 30, 1991 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FRN — Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |