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FDA 510(k) Application Details - K093665
Device Classification Name
Cystoscope And Accessories, Flexible/Rigid
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510(K) Number
K093665
Device Name
Cystoscope And Accessories, Flexible/Rigid
Applicant
BYRNE MEDICAL INC.
3150 POLLOK DR
CONROE, TX 77303 US
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Contact
DON BYRNE
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
11/25/2009
Decision Date
12/15/2009
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
Y
Expedited Review
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