The following data is part of a premarket notification filed by Coalescent Surgical with the FDA for Coalescent U-clip- And Accessories.
| Device ID | K023125 |
| 510k Number | K023125 |
| Device Name: | COALESCENT U-CLIP- AND ACCESSORIES |
| Classification | Suture, Nonabsorbable, Nitinol |
| 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 | NJU |
| CFR Regulation Number | 878.4495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-19 |
| Decision Date | 2002-12-18 |
| Summary: | summary |