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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
510(k) Number K904646
Device Name BCI-100 FECAL INCONTINENCE SYSTEM
Applicant
BIOCARE INTL.
3375 PARK AVENUE, SUITE 2000A
WANTAGH,  NY  11793
Applicant Contact STEVEN H REICHMAN
Correspondent
BIOCARE INTL.
3375 PARK AVENUE, SUITE 2000A
WANTAGH,  NY  11793
Correspondent Contact STEVEN H REICHMAN
Regulation Number876.1620
Classification Product Code
FAP  
Date Received10/11/1990
Decision Date 03/19/1991
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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