The following data is part of a premarket notification filed by Coalescent Surgical with the FDA for Modification To Coalescent Surgical U-clip And Accessories.
Device ID | K031623 |
510k Number | K031623 |
Device Name: | MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES |
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 |
Subsequent Product Code | NCA |
Subsequent Product Code | NJU |
CFR Regulation Number | 878.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-05-23 |
Decision Date | 2003-07-03 |
Summary: | summary |