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FDA 510(k) Application Details - K230603
Device Classification Name
Catheter, Conduction, Anesthetic
More FDA Info for this Device
510(K) Number
K230603
Device Name
Catheter, Conduction, Anesthetic
Applicant
Teleflex Medical
3015 Carrington Mill Blvd.
Morrisville, NC 27560 US
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Contact
Kristen Bisanz
Other 510(k) Applications for this Contact
Regulation Number
868.5120
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Classification Product Code
BSO
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More FDA Info for this Product Code
Date Received
03/03/2023
Decision Date
08/30/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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