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 |