510(k) K873929
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