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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collector, Ostomy
510(k) Number K873929
Device Name 'CATCH-IT' OR FECAL CONTAINMENT DEVICE
Applicant
Midwest Medical Co.
523 Wilkinson St.
Chelsea,  MI  48118
Applicant Contact JOHN TEMPLE
Correspondent
Midwest Medical Co.
523 Wilkinson St.
Chelsea,  MI  48118
Correspondent Contact JOHN TEMPLE
Regulation Number876.5900
Classification Product Code
EXB  
Date Received09/25/1987
Decision Date 12/03/1987
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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