HYPODERMIC NEEDLE-PRO SAFETY ALLERGY TRAY

Syringe, Antistick

SMITHS MEDICAL ASD, INC.

The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Hypodermic Needle-pro Safety Allergy Tray.

Pre-market Notification Details

Device IDK072482
510k NumberK072482
Device Name:HYPODERMIC NEEDLE-PRO SAFETY ALLERGY TRAY
ClassificationSyringe, Antistick
Applicant SMITHS MEDICAL ASD, INC. 10 BOWMAN DR. Keene,  NH  03431
ContactBrian Farias
CorrespondentBrian Farias
SMITHS MEDICAL ASD, INC. 10 BOWMAN DR. Keene,  NH  03431
Product CodeMEG  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-09-04
Decision Date2007-11-29
Summary:summary

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