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 |