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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Urinary Drainage Collection Kit, For Indwelling Catheter
510(k) Number K890096
Device Name BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG
Applicant
Medical Inventors Corp., Inc.
7575 Dr. Phillips Blvd.,
Suite #310
Orlando,  FL  32819
Applicant Contact ROLAND C ZAGNOLI
Correspondent
Medical Inventors Corp., Inc.
7575 Dr. Phillips Blvd.,
Suite #310
Orlando,  FL  32819
Correspondent Contact ROLAND C ZAGNOLI
Regulation Number876.5250
Classification Product Code
FCN  
Date Received01/10/1989
Decision Date 07/14/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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