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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Ureteral Disposable (X-Ray)
510(k) Number K903994
Device Name URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION
Applicant
APPLIED UROLOGY, INC.
26051 MERIT CIRCLE, BLDG. 104
LAGUNA HILLS,  CA  92653
Applicant Contact JO STEGWELL
Correspondent
APPLIED UROLOGY, INC.
26051 MERIT CIRCLE, BLDG. 104
LAGUNA HILLS,  CA  92653
Correspondent Contact JO STEGWELL
Regulation Number876.5130
Classification Product Code
FGF  
Date Received08/29/1990
Decision Date 10/19/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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