The following data is part of a premarket notification filed by Midwest Medical Co. with the FDA for 'catch-it' Or Fecal Containment Device.
Device ID | K873929 |
510k Number | K873929 |
Device Name: | 'CATCH-IT' OR FECAL CONTAINMENT DEVICE |
Classification | Collector, Ostomy |
Applicant | MIDWEST MEDICAL CO. 523 WILKINSON ST. Chelsea, MI 48118 |
Contact | John Temple |
Correspondent | John Temple MIDWEST MEDICAL CO. 523 WILKINSON ST. Chelsea, MI 48118 |
Product Code | EXB |
CFR Regulation Number | 876.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-25 |
Decision Date | 1987-12-03 |