The following data is part of a premarket notification filed by Mmi, Inc. with the FDA for G.i. Cleansing Kit.
| Device ID | K842130 |
| 510k Number | K842130 |
| Device Name: | G.I. CLEANSING KIT |
| Classification | Enema Kit |
| Applicant | MMI, INC. 19500 WEST EIGHT MILE RD. P.O. BOX 305 Southfield, MI 48037 |
| Contact | Martin Mattler |
| Correspondent | Martin Mattler MMI, INC. 19500 WEST EIGHT MILE RD. P.O. BOX 305 Southfield, MI 48037 |
| Product Code | FCE |
| CFR Regulation Number | 876.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-30 |
| Decision Date | 1984-08-08 |