PIGGYBACK IRRIGATING SYSTEM

System, Irrigation, Urological

KOSIN TECHNOLOGIES, LLC

The following data is part of a premarket notification filed by Kosin Technologies, Llc with the FDA for Piggyback Irrigating System.

Pre-market Notification Details

Device IDK040094
510k NumberK040094
Device Name:PIGGYBACK IRRIGATING SYSTEM
ClassificationSystem, Irrigation, Urological
Applicant KOSIN TECHNOLOGIES, LLC 3305 GREYFOX DRIVE Valparaiso,  IN  46383
ContactAvtar S Dhindsa
CorrespondentAvtar S Dhindsa
KOSIN TECHNOLOGIES, LLC 3305 GREYFOX DRIVE Valparaiso,  IN  46383
Product CodeLJH  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-01-16
Decision Date2004-04-15
Summary:summary

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