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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 K131169
Device Name MOZEC - RX PTCA BALLOON DILATATION CATHETER
Applicant
Meril Life Sciences Private Limited
5523 Research Park Dr., Suite 360
Baltimore,  MD  21228
Applicant Contact H. Semih Oktay
Correspondent
Meril Life Sciences Private Limited
5523 Research Park Dr., Suite 360
Baltimore,  MD  21228
Correspondent Contact H. Semih Oktay
Regulation Number870.5100
Classification Product Code
LOX  
Date Received04/24/2013
Decision Date 12/24/2013
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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