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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 K003958
Device Name COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE
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 Number878.4300
Classification Product Code
FZP  
Date Received12/21/2000
Decision Date 02/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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