UltiCare Disposable Pen Needles

Needle, Hypodermic, Single Lumen

UltiMed Incorporated

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

Pre-market Notification Details

Device IDK213407
510k NumberK213407
Device Name:UltiCare Disposable Pen Needles
ClassificationNeedle, Hypodermic, Single Lumen
Applicant UltiMed Incorporated 350 Highway 7, Suite 100 Excelsior,  MN  55331
ContactPaul Lewis
CorrespondentPrithul Bom
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 Received2021-10-19
Decision Date2021-12-16

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