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FDA 510(k) Application Details - K221683
Device Classification Name
Cystoscope And Accessories, Flexible/Rigid
More FDA Info for this Device
510(K) Number
K221683
Device Name
Cystoscope And Accessories, Flexible/Rigid
Applicant
Olympus Medical Systems Corporation
2951 Ishikawa-cho
Hachioji-Shi 192-8507 JP
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Contact
Shinichiro Kawachi
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
FAJ
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More FDA Info for this Product Code
Date Received
06/10/2022
Decision Date
01/20/2023
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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