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FDA 510(k) Application Details - K040127
Device Classification Name
Dilator, Catheter, Ureteral
More FDA Info for this Device
510(K) Number
K040127
Device Name
Dilator, Catheter, Ureteral
Applicant
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
SPENCER, IN 47460 US
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Contact
DEBBIE SCHMITT
Other 510(k) Applications for this Contact
Regulation Number
876.5470
More FDA Info for this Regulation Number
Classification Product Code
EZN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/21/2004
Decision Date
04/06/2004
Decision
SESK - SUBST EQUIV - KIT
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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