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FDA 510(k) Application Details - K223756
Device Classification Name
Catheter, Straight
More FDA Info for this Device
510(K) Number
K223756
Device Name
Catheter, Straight
Applicant
Dentsply Sirona
221 West Philadelphia Street, Suite 60W
York, PA 17401 US
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Contact
Laura Sobrin
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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
12/15/2022
Decision Date
05/04/2023
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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