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FDA 510(k) Application Details - K202141
Device Classification Name
Introducer, Catheter
More FDA Info for this Device
510(K) Number
K202141
Device Name
Introducer, Catheter
Applicant
Argon Medical Devices, Inc.
1445 Flat Creek Road
Athens, TX 75751 US
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Contact
Amy Clendening-Wheeler
Other 510(k) Applications for this Contact
Regulation Number
870.1340
More FDA Info for this Regulation Number
Classification Product Code
DYB
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More FDA Info for this Product Code
Date Received
07/31/2020
Decision Date
01/15/2021
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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