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FDA 510(k) Application Details - K103808
Device Classification Name
Catheters, Transluminal Coronary Angioplasty, Percutaneous
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510(K) Number
K103808
Device Name
Catheters, Transluminal Coronary Angioplasty, Percutaneous
Applicant
ORBUSNEICH MEDICAL, INC.
5363 N.W. 35TH AVE.
FT. LAUDERDALE, FL 33309-6315 US
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Contact
JOHN PAZIENZA
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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
12/29/2010
Decision Date
09/01/2011
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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