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FDA 510(k) Application Details - K192344
Device Classification Name
Catheters, Transluminal Coronary Angioplasty, Percutaneous
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510(K) Number
K192344
Device Name
Catheters, Transluminal Coronary Angioplasty, Percutaneous
Applicant
OrbusNeich Medical Trading Inc.
5363 NW 35th Avenue
Fort Lauderdale, FL 33309 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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Date Received
08/29/2019
Decision Date
09/19/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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