NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS

Set, Administration, Intravascular

CRITICAL DEVICE CORP.

The following data is part of a premarket notification filed by Critical Device Corp. with the FDA for Nima Needleless Injectionsite Master Adapter With Posiflow Positive Displacement Feature, And I.v. Sets.

Pre-market Notification Details

Device IDK964918
510k NumberK964918
Device Name:NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS
ClassificationSet, Administration, Intravascular
Applicant CRITICAL DEVICE CORP. 499 NIBUS ST. Brea,  CA  92621
ContactDan Hyun
CorrespondentDan Hyun
CRITICAL DEVICE CORP. 499 NIBUS ST. Brea,  CA  92621
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-12-09
Decision Date1997-04-14
Summary:summary

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