FDA 510(k) Application Details - K000278

Device Classification Name Clip, Implantable

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510(K) Number K000278
Device Name Clip, Implantable
Applicant VIVANT MEDICAL, INC.
3210-B ALPINE RD.
PORTOLA VALLEY, CA 94028 US
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Contact JACK W MOORMAN
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Regulation Number 878.4300

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Classification Product Code FZP
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Date Received 01/31/2000
Decision Date 06/23/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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