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FDA 510(k) Application Details - K162253
Device Classification Name
Catheter, Percutaneous
More FDA Info for this Device
510(K) Number
K162253
Device Name
Catheter, Percutaneous
Applicant
CREGANNA MEDICAL ASLO BUSINESS AS CREGGANNA TACTX MEDICAL
PARKMORE WEST
GALWAY IE
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Contact
ORLA HICKEY
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Regulation Number
870.1250
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Classification Product Code
DQY
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More FDA Info for this Product Code
Date Received
08/10/2016
Decision Date
01/06/2017
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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