FDA 510(k) Application Details - K130165

Device Classification Name Tape, Camera, Surgical

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510(K) Number K130165
Device Name Tape, Camera, Surgical
Applicant ADVANCED PLANIMETRIC SERVICES, LLC
610 BOULEVARD
ELMWOOD PARK, NJ 07407 US
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Contact MARTIN WENDELKEN
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Regulation Number 878.4160

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Classification Product Code FXN
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Date Received 01/23/2013
Decision Date 08/30/2013
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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