Device Classification Name |
clip, implantable
|
510(k) Number |
K031623 |
Device Name |
MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES |
Applicant |
COALESCENT SURGICAL |
559 EAST WEDDELL DR. |
SUNNYVALE,
CA
94089
|
|
Applicant Contact |
MICHAEL A DANIEL |
Correspondent |
COALESCENT SURGICAL |
559 EAST WEDDELL DR. |
SUNNYVALE,
CA
94089
|
|
Correspondent Contact |
MICHAEL A DANIEL |
Regulation Number | 878.4300
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/23/2003 |
Decision Date | 07/03/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|