The following data is part of a premarket notification filed by Tiller Mind Body, Inc. with the FDA for Colonic & Enema Nozzle.
| Device ID | K071057 |
| 510k Number | K071057 |
| Device Name: | COLONIC & ENEMA NOZZLE |
| Classification | Colonic Irrigation System |
| Applicant | TILLER MIND BODY, INC. 42 EAST WHISTERS BEND CIRCLE The Woodlands, TX 77384 |
| Contact | Harold L Jones |
| Correspondent | Harold L Jones TILLER MIND BODY, INC. 42 EAST WHISTERS BEND CIRCLE The Woodlands, TX 77384 |
| Product Code | KPL |
| CFR Regulation Number | 876.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-16 |
| Decision Date | 2007-10-05 |
| Summary: | summary |