510(k) K000388

CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL) by Clearwater Colon Hydrotherapy, Inc. — Product Code KPL

K000388 is an FDA 510(k) premarket notification submitted by Clearwater Colon Hydrotherapy, Inc. for the device "CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL)". The FDA issued a decision of Substantially Equivalent on August 8, 2000. 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.