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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name light, catheter, fiberoptic, glass, ureteral
510(k) Number K923436
Device Name ILLUMINATED URETERAL CATHETER
Applicant
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
P.O. BOX 227
SPENCER,  IN  47460
Applicant Contact TAMMY BACON
Correspondent
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
P.O. BOX 227
SPENCER,  IN  47460
Correspondent Contact TAMMY BACON
Regulation Number876.4020
Classification Product Code
FCS  
Date Received07/13/1992
Decision Date 03/05/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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