510(k) K873929

'CATCH-IT' OR FECAL CONTAINMENT DEVICE by Midwest Medical Co. — Product Code EXB

K873929 is an FDA 510(k) premarket notification submitted by Midwest Medical Co. for the device "'CATCH-IT' OR FECAL CONTAINMENT DEVICE". The FDA issued a decision of Substantially Equivalent on December 3, 1987. The device falls under product code EXB (Collector, Ostomy), a Class I device regulated under 21 CFR 876.5900.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1987
Date Received
September 25, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collector, Ostomy
Device Class
Class I
Regulation Number
876.5900
Review Panel
GU
Submission Type