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FDA 510(k) Application Details - K130165
Device Classification Name
Tape, Camera, Surgical
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
878.4160
More FDA Info for this Regulation Number
Classification Product Code
FXN
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More FDA Info for this Product Code
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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