'CATCH-IT' OR FECAL CONTAINMENT DEVICE

Collector, Ostomy

MIDWEST MEDICAL CO.

The following data is part of a premarket notification filed by Midwest Medical Co. with the FDA for 'catch-it' Or Fecal Containment Device.

Pre-market Notification Details

Device IDK873929
510k NumberK873929
Device Name:'CATCH-IT' OR FECAL CONTAINMENT DEVICE
ClassificationCollector, Ostomy
Applicant MIDWEST MEDICAL CO. 523 WILKINSON ST. Chelsea,  MI  48118
ContactJohn Temple
CorrespondentJohn Temple
MIDWEST MEDICAL CO. 523 WILKINSON ST. Chelsea,  MI  48118
Product CodeEXB  
CFR Regulation Number876.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-25
Decision Date1987-12-03

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