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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Injection Needle, Gastroenterology-Urology
510(k) Number K982890
Device Name ADVANCED UROSCIENCE INJECTION NEEDLE
Applicant
ADVANCED UROSCIENCE, INC.
1290 HAMMOND RD.
ST. PAUL,  MN  55110
Applicant Contact KAREN E PETERSON
Correspondent
ADVANCED UROSCIENCE, INC.
1290 HAMMOND RD.
ST. PAUL,  MN  55110
Correspondent Contact KAREN E PETERSON
Regulation Number876.1500
Classification Product Code
FBK  
Date Received08/17/1998
Decision Date 10/26/1998
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
Predetermined Change
Control Plan Authorized		 No
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