The following data is part of a premarket notification filed by Coalescent Surgical with the FDA for Coalescent U-clip Delivery And Disposal Device.
| Device ID | K003958 |
| 510k Number | K003958 |
| Device Name: | COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE |
| Classification | Clip, Implantable |
| Applicant | COALESCENT SURGICAL 559 EAST WEDDELL DR. Sunnyvale, CA 94089 |
| Contact | Michael A Daniel |
| Correspondent | Michael A Daniel COALESCENT SURGICAL 559 EAST WEDDELL DR. Sunnyvale, CA 94089 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-21 |
| Decision Date | 2001-02-06 |