AUTOJECT 2

Introducer, Syringe Needle

OWEN MUMFORD USA, INC.

The following data is part of a premarket notification filed by Owen Mumford Usa, Inc. with the FDA for Autoject 2.

Pre-market Notification Details

Device IDK013362
510k NumberK013362
Device Name:AUTOJECT 2
ClassificationIntroducer, Syringe Needle
Applicant OWEN MUMFORD USA, INC. 1755-A WEST OAK COMMONS CT. Marietta,  GA  30062
ContactRobert Shaw
CorrespondentRobert Shaw
OWEN MUMFORD USA, INC. 1755-A WEST OAK COMMONS CT. Marietta,  GA  30062
Product CodeKZH  
CFR Regulation Number880.6920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-10-10
Decision Date2001-11-13
Summary:summary

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