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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheters, Transluminal Coronary Angioplasty, Percutaneous
510(k) Number K162434
Device Name NC Gallant PTCA Catheter
Applicant
Medinol , Ltd.
Kiryat Atidim, Bldg. 8
Tel Aviv,  IL 6158101
Applicant Contact MICHAL HERSHKOVITZ
Correspondent
Cardiomed Device Consultants
5523 Research Park Dr., Suite 205
Baltimore,  MD  21228
Correspondent Contact H. SEMIH OKTAY
Regulation Number870.5100
Classification Product Code
LOX  
Date Received08/31/2016
Decision Date 01/19/2017
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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