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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name wire, guide, catheter
510(k) Number K100425
Device Name HASKAL TORQUE DEVICE
Original Applicant
ELCAM MEDICAL A.C.A.L.
kibbutz bar-am
mp. merom hagalil,  IL 13860
Original Contact shay shaham
Regulation Number870.1330
Classification Product Code
DQX  
Date Received02/16/2010
Decision Date 06/17/2010
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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