AUTOJECT 2 FOR GLASSY SYRINGE

Introducer, Syringe Needle

OWEN MUMFORD, LTD.

The following data is part of a premarket notification filed by Owen Mumford, Ltd. with the FDA for Autoject 2 For Glassy Syringe.

Pre-market Notification Details

Device IDK122837
510k NumberK122837
Device Name:AUTOJECT 2 FOR GLASSY SYRINGE
ClassificationIntroducer, Syringe Needle
Applicant OWEN MUMFORD, LTD. BROOK HILL Woodstock, Oxfordshire,  GB 0x20itu
ContactDarren Mansell
CorrespondentDarren Mansell
OWEN MUMFORD, LTD. BROOK HILL Woodstock, Oxfordshire,  GB 0x20itu
Product CodeKZH  
CFR Regulation Number880.6920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-09-17
Decision Date2012-10-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15016189106015 K122837 000

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