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FDA 510(k) Application Details - K992527
Device Classification Name
Ureteroscope And Accessories, Flexible/Rigid
More FDA Info for this Device
510(K) Number
K992527
Device Name
Ureteroscope And Accessories, Flexible/Rigid
Applicant
FIBER IMAGING TECHNOLOGIES, INC.
45 PONTIAC RD.
NEWTON, MA 02468 US
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Contact
JOSEPH RESS
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
07/28/1999
Decision Date
10/13/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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