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FDA 510(k) Application Details - K131169
Device Classification Name
Catheters, Transluminal Coronary Angioplasty, Percutaneous
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510(K) Number
K131169
Device Name
Catheters, Transluminal Coronary Angioplasty, Percutaneous
Applicant
MERIL LIFE SCIENCES PRIVATE LIMITED
5523 RESEARCH PARK DR., SUITE 360
BALTIMORE, MD 21228 US
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Contact
H. Semih Oktay
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
LOX
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More FDA Info for this Product Code
Date Received
04/24/2013
Decision Date
12/24/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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