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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 K992391
Device Name UROSURGE SPIRALFLO URETERAL STENT
Applicant
UROSURGE, INC.
2660 CROSSPARK RD.
CORALVILLE,  IA  52241
Applicant Contact STEVEN J PREISS
Correspondent
UROSURGE, INC.
2660 CROSSPARK RD.
CORALVILLE,  IA  52241
Correspondent Contact STEVEN J PREISS
Regulation Number876.4620
Classification Product Code
FAD  
Date Received07/19/1999
Decision Date 08/18/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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