EQUASHIELD SYSTEM

Set, I.v. Fluid Transfer

PLASTMED, LTD.

The following data is part of a premarket notification filed by Plastmed, Ltd. with the FDA for Equashield System.

Pre-market Notification Details

Device IDK083152
510k NumberK083152
Device Name:EQUASHIELD SYSTEM
ClassificationSet, I.v. Fluid Transfer
Applicant PLASTMED, LTD. BUILDING 7 P.O.B. 26 Tefen Industrial Park,  IL 24959
ContactElissa Burg
CorrespondentElissa Burg
PLASTMED, LTD. BUILDING 7 P.O.B. 26 Tefen Industrial Park,  IL 24959
Product CodeLHI  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-10-24
Decision Date2009-02-02
Summary:summary

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