FDA 510(k) Application Details - K070426

Device Classification Name Tape, Camera, Surgical

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510(K) Number K070426
Device Name Tape, Camera, Surgical
Applicant ARANZ MEDICAL LIMITED
GROUND FLOOR ST ELMO COURTS
47 HEREFORD ST. PO BOX 3894
CHRISTCHURCH, CANTERBURY 8013 NZ
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Contact SHANE GOODWIN
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Regulation Number 878.4160

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Classification Product Code FXN
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Date Received 02/13/2007
Decision Date 06/29/2007
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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