ULTICARE DISPOSABLE PEN NEEDLES

Needle, Hypodermic, Single Lumen

ULTIMED, INC.

The following data is part of a premarket notification filed by Ultimed, Inc. with the FDA for Ulticare Disposable Pen Needles.

Pre-market Notification Details

Device IDK100812
510k NumberK100812
Device Name:ULTICARE DISPOSABLE PEN NEEDLES
ClassificationNeedle, Hypodermic, Single Lumen
Applicant ULTIMED, INC. 5353 WAYZATA BOULEVARD SUITE 505 Minneapolis,  MN  55416 -1334
ContactMary Beth Henderson
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2010-03-23
Decision Date2010-06-03
Summary:summary

NIH GUDID Devices

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