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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
Applicant
ROCHESTER MEDICAL CORP.
ONE ROCHESTER MEDICAL DR.
STEWARTVILLE,  MN  55976
Applicant Contact ROB ANGLIN
Correspondent
ROCHESTER MEDICAL CORP.
ONE ROCHESTER MEDICAL DR.
STEWARTVILLE,  MN  55976
Correspondent Contact ROB ANGLIN
Regulation Number876.5130
Classification Product Code
EZD  
Date Received09/11/2012
Decision Date 05/14/2013
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
Recalls CDRH Recalls
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