CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL)— 510(k) K000388

Name: FDA 510(k) clearance K000388
Creator: U.S. Food and Drug Administration
Published: 2000-08-08

Substantially Equivalent

Clearwater Colon Hydrotherapy, Inc.

FDA 510(k) clearance K000388 for CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL), Substantially Equivalent on 2000-08-08. Applicant: Clearwater Colon Hydrotherapy, Inc.. Device class: 2.

Clearance details

Applicant: Clearwater Colon Hydrotherapy, Inc.
Product code: Code KPL
Device class: Class 2
Regulation: 21 CFR 876.5220
Advisory panel: Gastroenterology, Urology
Date received: 2000-02-07
Decision date: 2000-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ocala, FL, US

Download summary PDF View on FDA.gov ↗

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