FDA 510(k) Application Details - K030269

Device Classification Name Clip, Implantable

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510(K) Number K030269
Device Name Clip, Implantable
Applicant GENICON, LC
P.O. BOX 780038
ORLANDO, FL 32878-0038 US
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Contact FRANK GOLDFARB
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Regulation Number 878.4300

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Classification Product Code FZP
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Date Received 01/27/2003
Decision Date 03/20/2003
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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