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FDA 510(k) Application Details - K111284
Device Classification Name
Catheters, Transluminal Coronary Angioplasty, Percutaneous
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510(K) Number
K111284
Device Name
Catheters, Transluminal Coronary Angioplasty, Percutaneous
Applicant
OSTIAL CORPORATION
510 CLYDE AVENUE
MOUNTAIN VIEW, CA 94043 US
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Contact
Mark Smutka
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Regulation Number
000.0000
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Classification Product Code
LOX
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Date Received
05/06/2011
Decision Date
08/17/2011
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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