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510(k) K100425

HASKAL TORQUE DEVICE by Elcam Medical Acal — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2010
Date Received
February 16, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
Submission Type

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