FDA 510(k) Application Details - K964470

Device Classification Name Clip, Implantable

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510(K) Number K964470
Device Name Clip, Implantable
Applicant APPLIED MEDICAL RESOURCES
26051 MERIT CIRCLE
BUILDING 104
LAGUNA HILLS, CA 92653 US
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Contact HOWARD V ROWE
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Regulation Number 878.4300

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Classification Product Code FZP
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Date Received 11/07/1996
Decision Date 01/22/1997
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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