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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 K070426
Device Name SILHOUETTE, MODEL 1000.01
Applicant
ARANZ MEDICAL LIMITED
GROUND FLOOR ST ELMO COURTS
47 HEREFORD ST. PO BOX 3894
christchurch, canterbury,  NZ 8013
Applicant Contact shane goodwin
Correspondent
ARANZ MEDICAL LIMITED
GROUND FLOOR ST ELMO COURTS
47 HEREFORD ST. PO BOX 3894
christchurch, canterbury,  NZ 8013
Correspondent Contact shane goodwin
Regulation Number878.4160
Classification Product Code
FXN  
Date Received02/13/2007
Decision Date 06/29/2007
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
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