K965208 is an FDA 510(k) clearance for the POLYFIN EXTENSION SET, MODELS 126 AND 128. This device is classified as a Tubing, Fluid Delivery (Class II - Special Controls, product code FPK).
Submitted by Medtronic Minimed (Sylmar, US). The FDA issued a Cleared decision on February 26, 1997, 61 days after receiving the submission on December 27, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K965208 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 1996 |
| Decision Date | February 26, 1997 |
| Days to Decision | 61 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FPK — Tubing, Fluid Delivery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |