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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 K915166
Device Name MICROCYCLER
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 Received11/15/1991
Decision Date 09/07/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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