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FDA 510(k) Application Details - K993041
Device Classification Name
Cystoscope And Accessories, Flexible/Rigid
More FDA Info for this Device
510(K) Number
K993041
Device Name
Cystoscope And Accessories, Flexible/Rigid
Applicant
THE OLYMPUS OPTICAL CO.
1129 BLOOMFIELD AVE.
WEST CALDWELL, NJ 07006 US
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Contact
ROBERT SHIFF
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
FAJ
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More FDA Info for this Product Code
Date Received
09/10/1999
Decision Date
03/30/2000
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
FDA Source Information for K993041
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