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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 K123792
Device Name HORIZON XVU (FFR)
Applicant
Mennen Medical , Ltd.
4 Hayarden St., Yavne
P.O. Box 102
Rohovot,  IL 76100
Applicant Contact IFAT SHWARTS
Correspondent
Mennen Medical , Ltd.
4 Hayarden St., Yavne
P.O. Box 102
Rohovot,  IL 76100
Correspondent Contact IFAT SHWARTS
Regulation Number870.1330
Classification Product Code
DQX  
Date Received12/10/2012
Decision Date 08/30/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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