JIMMY JOHN III, COLONIC IRRIGATION SYSTEM

Colonic Irrigation System

COLON THERAPEUTICS

The following data is part of a premarket notification filed by Colon Therapeutics with the FDA for Jimmy John Iii, Colonic Irrigation System.

Pre-market Notification Details

Device IDK870376
510k NumberK870376
Device Name:JIMMY JOHN III, COLONIC IRRIGATION SYSTEM
ClassificationColonic Irrigation System
Applicant COLON THERAPEUTICS 2729 UPTON DR. Port Arthur,  TX  77642
ContactJimmy Girouard
CorrespondentJimmy Girouard
COLON THERAPEUTICS 2729 UPTON DR. Port Arthur,  TX  77642
Product CodeKPL  
CFR Regulation Number876.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-01-29
Decision Date1987-03-17

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