The following data is part of a premarket notification filed by Mmi, Inc. with the FDA for Dual Flex Non-latex.
| Device ID | K905026 |
| 510k Number | K905026 |
| Device Name: | DUAL FLEX NON-LATEX |
| Classification | Catheter, Retention, Barium Enema With Bag |
| Applicant | MMI, INC. 19500 WEST EIGHT MILE RD. P.O. BOX 305 Southfield, MI 48037 |
| Contact | Mattler |
| Correspondent | Mattler MMI, INC. 19500 WEST EIGHT MILE RD. P.O. BOX 305 Southfield, MI 48037 |
| Product Code | FGD |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-07 |
| Decision Date | 1991-12-18 |