JIMMY JOHN III, RECTAL NOZZLE (MODIFICATION)

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, Rectal Nozzle (modification).

Pre-market Notification Details

Device IDK860943
510k NumberK860943
Device Name:JIMMY JOHN III, RECTAL NOZZLE (MODIFICATION)
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 Received1986-03-12
Decision Date1986-05-15

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