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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 K981489
Device Name UROSURGE SPIRASTENT PLUS URETERAL STENT
Applicant
UROSURGE, INC.
116 VILLAGE BLVD., SUITE 200
PRINCETON,  NJ  08540 -5799
Applicant Contact THOMAS BECZE
Correspondent
UROSURGE, INC.
116 VILLAGE BLVD., SUITE 200
PRINCETON,  NJ  08540 -5799
Correspondent Contact THOMAS BECZE
Regulation Number876.4620
Classification Product Code
FAD  
Date Received04/27/1998
Decision Date 05/29/1998
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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