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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 K121337
Device Name UROPLASTY RIGID ENDOSCPIC NEEDLES
Applicant
UROPLASTY, INC.
5420 FELTL RD.
MINNETONKA,  MN  55343
Applicant Contact EMILY METCALFE
Correspondent
UROPLASTY, INC.
5420 FELTL RD.
MINNETONKA,  MN  55343
Correspondent Contact EMILY METCALFE
Regulation Number876.1500
Classification Product Code
FBK  
Date Received05/03/2012
Decision Date 08/03/2012
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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