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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 K091391
Device Name UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518
Applicant
UROPLASTY, INC.
5420 FELTL RD.
MINNETONKA,  MN  55343
Applicant Contact MICHAEL MORRELL
Correspondent
UROPLASTY, INC.
5420 FELTL RD.
MINNETONKA,  MN  55343
Correspondent Contact MICHAEL MORRELL
Regulation Number876.1500
Classification Product Code
FBK  
Date Received05/11/2009
Decision Date 06/30/2009
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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