ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER

Container, Sharps

ULTIMED, INC.

The following data is part of a premarket notification filed by Ultimed, Inc. with the FDA for Ultiguard Home Insulin Pen Needle Dispenser And Sharps Container.

Pre-market Notification Details

Device IDK081449
510k NumberK081449
Device Name:ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER
ClassificationContainer, Sharps
Applicant ULTIMED, INC. 5353 WAYZATA BLVD. SUITE 505 Minneapolis,  MN  55416 -1334
ContactC. Stamp
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeMMK  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2008-05-23
Decision Date2008-06-03
Summary:summary

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