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FDA 510(k) Application Details - K062707
Device Classification Name
Ureteroscope And Accessories, Flexible/Rigid
More FDA Info for this Device
510(K) Number
K062707
Device Name
Ureteroscope And Accessories, Flexible/Rigid
Applicant
INNOVATIVE ENDOSCOPY COMPONENTS, LLC.
731-733 SHOTGUN RD.
FT. LAUDERDALE, FL 33326 US
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Contact
GERALD GOIGITZER
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
FGB
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More FDA Info for this Product Code
Date Received
09/11/2006
Decision Date
12/08/2006
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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