510(k) K071057
K071057 is an FDA 510(k) premarket notification submitted by Tiller Mind Body, Inc. for the device "COLONIC & ENEMA NOZZLE". The FDA issued a decision of Substantially Equivalent on October 5, 2007. The device falls under product code KPL (Colonic Irrigation System), a Class II device regulated under 21 CFR 876.5220. Tiller Mind Body, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 5, 2007
- Date Received
- April 16, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Colonic Irrigation System
- Device Class
- Class II
- Regulation Number
- 876.5220
- Review Panel
- GU
- Submission Type