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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clip, Implantable
510(k) Number K031623
Device Name MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES
Applicant
Coalescent Surgical
559 E. Weddell Dr.
Sunnyvale,  CA  94089
Applicant Contact MICHAEL A DANIEL
Correspondent
Coalescent Surgical
559 E. Weddell Dr.
Sunnyvale,  CA  94089
Correspondent Contact MICHAEL A DANIEL
Regulation Number878.4300
Classification Product Code
FZP  
Subsequent Product Codes
NCA   NJU  
Date Received05/23/2003
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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