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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 K000278
Device Name VIVANT MEDICAL BIOPSY MARKER SYSTEM
Applicant
VIVANT MEDICAL, INC.
3210-B ALPINE RD.
PORTOLA VALLEY,  CA  94028
Applicant Contact JACK W MOORMAN
Correspondent
VIVANT MEDICAL, INC.
3210-B ALPINE RD.
PORTOLA VALLEY,  CA  94028
Correspondent Contact JACK W MOORMAN
Regulation Number878.4300
Classification Product Code
FZP  
Date Received01/31/2000
Decision Date 06/23/2000
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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