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510(k) K000388

Device
CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL)
Applicant
CLEARWATER COLON HYDROTHERAPY, INC.
510(k) number
K000388
Product code
KPL  
Decision
Substantially Equivalent (SESE)
Decision date
2000-08-08
Date received
2000-02-07
Regulation
876.5220
Classification name
Colonic Irrigation System
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
STUART K BAKER
Address
4451-A S. Pine Ave. Ocala FL US 34480 34480

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KPL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K201861Bio Fluff SystemGnali Bocia S.R.L.2022-03-02
K180800Colonic Plus Regular, Small, and Straight Shape HydrokitColonic Plus2018-06-01
K152834Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10Colonplus Equipments & Speculums, S.L.2016-08-10
K150381AQUA CLEANSEQuality Medical Supply, Inc.2015-09-11
K131852HC-1 AND HC-1 CLASSICTranscendencias Comerciales SL Transcom2014-04-17
K094022THE WATER LILYClearwater Products, LLC2010-06-11
K071057COLONIC & ENEMA NOZZLETiller Mind Body, Inc.2007-10-05
K051344COLONIC AND ENEMA NOZZLEUltimate Concepts, Inc.2005-08-18
K050992CONMED IRRIGATION NOZZLEConmedcorp2005-07-14
K050112PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117Prime Pacific Health Innovations Corporation2005-03-15
K033149ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEMUltimate Concepts, Inc.2004-03-23
K003720ANGEL OF WATER COLON HYDROTHERAPY SYSTEMLifestream Purfication Systems, LLC2002-06-27
K002102GENTLE COLONICS IRRIGATION SYSTEMGentle Colonics, Inc.2002-02-06
K000031AQUANET, MODEL EC 2000Prime Pacific Health Innovations Corporation2001-09-10
K980868GC IRRIGATORGentle Colonics, Inc.1998-08-06

Legacy Summary#

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FDA Review#

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