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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tape, Camera, Surgical
510(k) Number K130165
Device Name PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0
Applicant
ADVANCED PLANIMETRIC SERVICES, LLC
610 BOULEVARD
ELMWOOD PARK,  NJ  07407
Applicant Contact MARTIN WENDELKEN
Correspondent
ADVANCED PLANIMETRIC SERVICES, LLC
610 BOULEVARD
ELMWOOD PARK,  NJ  07407
Correspondent Contact MARTIN WENDELKEN
Regulation Number878.4160
Classification Product Code
FXN  
Date Received01/23/2013
Decision Date 08/30/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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