The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for U-clip Uni-fire, Model M65.
| Device ID | K081082 |
| 510k Number | K081082 |
| Device Name: | U-CLIP UNI-FIRE, MODEL M65 |
| Classification | Clip, Implantable |
| Applicant | MEDTRONIC INC. 3051 S. NEWCOMBE WAY Lakewood, CO 80227 |
| Contact | David D Cox |
| Correspondent | David D Cox MEDTRONIC INC. 3051 S. NEWCOMBE WAY Lakewood, CO 80227 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-16 |
| Decision Date | 2008-05-07 |
| Summary: | summary |