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FDA 510(k) Application Details - K083788
Device Classification Name
Catheter, Ureteral, Gastro-Urology
More FDA Info for this Device
510(K) Number
K083788
Device Name
Catheter, Ureteral, Gastro-Urology
Applicant
ENDO OPTIKS, INC.
39 SYCAMORE AVE.
LITTLE SILVER, NJ 07739-1208 US
Other 510(k) Applications for this Company
Contact
DONALD R WATSON
Other 510(k) Applications for this Contact
Regulation Number
876.5130
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Classification Product Code
EYB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/19/2008
Decision Date
03/03/2009
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
N
Expedited Review
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