Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01

Set, I.v. Fluid Transfer

BIOJECT MEDICAL TECHNOLOGIES INC.

The following data is part of a premarket notification filed by Bioject Medical Technologies Inc. with the FDA for Q-cap Needle-free Reconstitution 13mm Vial Adapter, Model 6100-01.

Pre-market Notification Details

Device IDK041564
510k NumberK041564
Device Name:Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01
ClassificationSet, I.v. Fluid Transfer
Applicant BIOJECT MEDICAL TECHNOLOGIES INC. 211 SOMERVILLE ROAD Bedminster,  NJ  07921
ContactLaurence A Potter
CorrespondentLaurence A Potter
BIOJECT MEDICAL TECHNOLOGIES INC. 211 SOMERVILLE ROAD Bedminster,  NJ  07921
Product CodeLHI  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-06-10
Decision Date2004-07-16
Summary:summary

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