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510(k) K070426

SILHOUETTE, MODEL 1000.01 by Aranz Medical Limited — Product Code FXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2007
Date Received
February 13, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tape, Camera, Surgical
Device Class
Class I
Regulation Number
878.4160
Review Panel
SU
Submission Type

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