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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, straight
510(k) Number K122785
Device Name HYDROSIL; MAGIC; PERSONAL CATHETER
Original Applicant
ROCHESTER MEDICAL CORP.
one rochester medical dr.
stewartville,  MN  55976
Original Contact rob anglin
Regulation Number876.5130
Classification Product Code
EZD  
Date Received09/11/2012
Decision Date 05/14/2013
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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