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FDA 510(k) Application Details - K070426
Device Classification Name
Tape, Camera, Surgical
More FDA Info for this Device
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
Other 510(k) Applications for this Company
Contact
SHANE GOODWIN
Other 510(k) Applications for this Contact
Regulation Number
878.4160
More FDA Info for this Regulation Number
Classification Product Code
FXN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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