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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 K082805
Device Name PAGUAMEDICINA STRUCTURAL HYDROGEL PEDIATRIC URETERAL STENT, MODEL NP330-XXX
Applicant
Q UROLOGICAL CORPORATION
1E MELVIN STREET
P.O. BOX 793
NATICK,  MA  01760
Applicant Contact SCOTT M EPSTEIN
Correspondent
Q UROLOGICAL CORPORATION
1E MELVIN STREET
P.O. BOX 793
NATICK,  MA  01760
Correspondent Contact SCOTT M EPSTEIN
Regulation Number876.4620
Classification Product Code
FAD  
Date Received09/24/2008
Decision Date 01/20/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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