HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710

Heparin, Vascular Access Flush

APP PHARMACEUTICALS, LLC

The following data is part of a premarket notification filed by App Pharmaceuticals, Llc with the FDA for Heparin Lock Flush Solution Usp, Models 504401, 504411, 504505, 505701, 504901, 1710.

Pre-market Notification Details

Device IDK092938
510k NumberK092938
Device Name:HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710
ClassificationHeparin, Vascular Access Flush
Applicant APP PHARMACEUTICALS, LLC 962 ALLEGRO LN. Apollo Beach,  FL  33572
ContactArthur Ward
CorrespondentArthur Ward
APP PHARMACEUTICALS, LLC 962 ALLEGRO LN. Apollo Beach,  FL  33572
Product CodeNZW  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2009-09-24
Decision Date2010-06-18
Summary:summary

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