510(k) K003720

ANGEL OF WATER COLON HYDROTHERAPY SYSTEM by Lifestream Purfication Systems, LLC — Product Code KPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2002
Date Received
December 4, 2000
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