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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 K961697
Device Name OPTICON FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE
Applicant
Medical Device Intl., Inc.
5116 Birch Rd.
Minnetonka,  MN  55345
Applicant Contact GREG SACHS
Correspondent
Medical Device Intl., Inc.
5116 Birch Rd.
Minnetonka,  MN  55345
Correspondent Contact GREG SACHS
Regulation Number876.5130
Classification Product Code
EZL  
Date Received05/02/1996
Decision Date 08/30/1996
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
Predetermined Change
Control Plan Authorized		 No
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