ULTRASAFE PLUS PASSIVE NEEDLE GUARD

Syringe, Antistick

SAFETY SYRINGES, INC.

The following data is part of a premarket notification filed by Safety Syringes, Inc. with the FDA for Ultrasafe Plus Passive Needle Guard.

Pre-market Notification Details

Device IDK123743
510k NumberK123743
Device Name:ULTRASAFE PLUS PASSIVE NEEDLE GUARD
ClassificationSyringe, Antistick
Applicant SAFETY SYRINGES, INC. 2875 LOKER AVENUE EAST Carlsbad,  CA  92010
ContactSuzanne Richardson
CorrespondentSuzanne Richardson
SAFETY SYRINGES, INC. 2875 LOKER AVENUE EAST Carlsbad,  CA  92010
Product CodeMEG  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-12-06
Decision Date2013-03-26
Summary:summary

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