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FDA 510(k) Application Details - K221593
Device Classification Name
Catheter, Straight
More FDA Info for this Device
510(K) Number
K221593
Device Name
Catheter, Straight
Applicant
ConvaTec, Inc.
7815 National Service Road, Suite 600
Greensboro, NC 27409 US
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Contact
Courtney Smith
Other 510(k) Applications for this Contact
Regulation Number
876.5130
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Classification Product Code
EZD
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More FDA Info for this Product Code
Date Received
06/02/2022
Decision Date
11/17/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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