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FDA 510(k) Application Details - K201897
Device Classification Name
Ureteroscope And Accessories, Flexible/Rigid
More FDA Info for this Device
510(K) Number
K201897
Device Name
Ureteroscope And Accessories, Flexible/Rigid
Applicant
Richard Wolf Medical Instruments Corporation
353 Corporate Woods Parkway
Vernon Hills, IL 60061 US
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Contact
Michael Loiterman
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
FGB
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More FDA Info for this Product Code
Date Received
07/08/2020
Decision Date
01/15/2021
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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