510(k) K033149
K033149 is an FDA 510(k) premarket notification submitted by Ultimate Concepts, Inc. for the device "ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM". The FDA issued a decision of Substantially Equivalent on March 23, 2004. The device falls under product code KPL (Colonic Irrigation System), a Class II device regulated under 21 CFR 876.5220. Ultimate Concepts, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 23, 2004
- Date Received
- September 30, 2003
- 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