510(k) K970482
K970482 is an FDA 510(k) premarket notification submitted by Srs Intl. for the device "TRANSCOM COLON HYDROTHERAPY MODEL HC-2000". The FDA issued a decision of Substantially Equivalent on October 31, 1997. The device falls under product code KPL (Colonic Irrigation System), a Class II device regulated under 21 CFR 876.5220.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 1997
- Date Received
- February 10, 1997
- 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