ANGEL OF WATER COLON HYDROTHERAPY SYSTEM

Colonic Irrigation System

LIFESTREAM PURFICATION SYSTEMS, LLC.

The following data is part of a premarket notification filed by Lifestream Purfication Systems, Llc. with the FDA for Angel Of Water Colon Hydrotherapy System.

Pre-market Notification Details

Device IDK003720
510k NumberK003720
Device Name:ANGEL OF WATER COLON HYDROTHERAPY SYSTEM
ClassificationColonic Irrigation System
Applicant LIFESTREAM PURFICATION SYSTEMS, LLC. 6401 MEADOWS WEST DR. Fort Worth,  TX  76132
ContactRichard A Hamer
CorrespondentAmy H Bruno
LIFESTREAM PURFICATION SYSTEMS, LLC. 7303 Burleson Rd., Ste 801 Austin,  TX  78744
Product CodeKPL  
CFR Regulation Number876.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-12-04
Decision Date2002-06-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B149CM11 K003720 000

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