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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
Models MRN-420, MRN-518
Device Name UROPLASTY RIGID ENDOSCPIC NEEDLES
Original Applicant
UROPLASTY, INC.
5420 feltl rd.
minnetonka,  MN  55343
Original Contact emily metcalfe
Regulation Number876.1500
Classification Product Code
FBK  
Date Received05/03/2012
Decision Date 08/03/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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