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FDA 510(k) Application Details - K970041
Device Classification Name
Dilator, Catheter, Ureteral
More FDA Info for this Device
510(K) Number
K970041
Device Name
Dilator, Catheter, Ureteral
Applicant
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
P.O. BOX 227
SPENCER, IN 47460 US
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Contact
TAMMY BACON
Other 510(k) Applications for this Contact
Regulation Number
876.5470
More FDA Info for this Regulation Number
Classification Product Code
EZN
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More FDA Info for this Product Code
Date Received
01/06/1997
Decision Date
03/19/1997
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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