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510(k) K130165

Device
PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0
Applicant
ADVANCED PLANIMETRIC SERVICES, LLC
510(k) number
K130165
Product code
FXN  
Decision
Substantially Equivalent (SESE)
Decision date
2013-08-30
Date received
2013-01-23
Regulation
878.4160
Classification name
Tape, Camera, Surgical
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MARTIN WENDELKEN
Address
610 Blvd. Elmwood Park NJ US 07407 07407

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FXN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K131596WOUND MEASURING & MONITORING DEVICEWoundvision, LLC2013-12-11
K070426SILHOUETTE, MODEL 1000.01Aranz Medical Limited2007-06-29
K962148VERGE VIDEOMETERVerg, Inc.1996-12-20

Legacy Summary#

summary

FDA Review#

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