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510(k) K070426

Device
SILHOUETTE, MODEL 1000.01
Applicant
ARANZ MEDICAL LIMITED
510(k) number
K070426
Product code
FXN  
Decision
Substantially Equivalent (SESE)
Decision date
2007-06-29
Date received
2007-02-13
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
SHANE GOODWIN
Address
Ground Floor St. Elmo Ct.s 47 Hereford St. P.O. Box 3894 Christchurch, Canterbury NZ 8013 8013

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
K130165PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0Advanced Planimetric Services, LLC2013-08-30
K962148VERGE VIDEOMETERVerg, Inc.1996-12-20

Legacy Summary#

summary

FDA Review#

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