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FDA 510(k) Application Details - K014075
Device Classification Name
Wire, Guide, Catheter
More FDA Info for this Device
510(K) Number
K014075
Device Name
Wire, Guide, Catheter
Applicant
BAYLIS MEDICAL CO., INC.
5160 EXPLORER DRIVE, UNIT 33
MISSISSAUGA, ONTARIO L4W-4T7 CA
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Contact
KRIS SHAH
Other 510(k) Applications for this Contact
Regulation Number
870.1330
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Classification Product Code
DQX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/11/2001
Decision Date
03/07/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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