510(k) K942867

CLEARWATER COLON HYDROTHERAPY MODEL PPC-101 by Clearwater Colon Hydrotherapy, Inc. — Product Code KPL

K942867 is an FDA 510(k) premarket notification submitted by Clearwater Colon Hydrotherapy, Inc. for the device "CLEARWATER COLON HYDROTHERAPY MODEL PPC-101". The FDA issued a decision of Substantially Equivalent on June 26, 1996. The device falls under product code KPL (Colonic Irrigation System), a Class II device regulated under 21 CFR 876.5220. Clearwater Colon Hydrotherapy, Inc. has at least 1 other 510(k) clearance on record.