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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, retention type, balloon
510(k) Number K970716
Device Name OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE
Applicant
OPTICON MEDICAL, INC.
14505 21ST AVENUE NORTH
SUITE #216
MINNEAPOLIS,  MN  55447
Applicant Contact GREG SACHS
Correspondent
OPTICON MEDICAL, INC.
14505 21ST AVENUE NORTH
SUITE #216
MINNEAPOLIS,  MN  55447
Correspondent Contact GREG SACHS
Regulation Number876.5130
Classification Product Code
EZL  
Date Received02/27/1997
Decision Date 05/16/1997
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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