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FDA 510(k) Application Details - K191546
Device Classification Name
Introducer, Catheter
More FDA Info for this Device
510(K) Number
K191546
Device Name
Introducer, Catheter
Applicant
Baylis Medical Company Inc.
2580 Matheson Blvd. East
Mississauga L4W 4J1 CA
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Contact
May Tsai
Other 510(k) Applications for this Contact
Regulation Number
870.1340
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Classification Product Code
DYB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/12/2019
Decision Date
08/02/2019
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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