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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stent, ureteral
510(k) Number K925282
Device Name UROLOGICAL CATHETER AND ACCESSORIES
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 Number876.4620
Classification Product Code
FAD  
Date Received10/20/1992
Decision Date 01/13/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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