The following data is part of a premarket notification filed by Medtronic Minimed with the FDA for Polyfin Extension Set, Models 126 And 128.
| Device ID | K965208 |
| 510k Number | K965208 |
| Device Name: | POLYFIN EXTENSION SET, MODELS 126 AND 128 |
| Classification | Tubing, Fluid Delivery |
| Applicant | MEDTRONIC MINIMED 12744 SAN FERNANDO RD. Sylmar, CA 91342 |
| Contact | Terrance H Gregg |
| Correspondent | Terrance H Gregg MEDTRONIC MINIMED 12744 SAN FERNANDO RD. Sylmar, CA 91342 |
| Product Code | FPK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-27 |
| Decision Date | 1997-02-26 |
| Summary: | summary |