ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLE

Syringe, Antistick

ULTIMED INCORPORATED

The following data is part of a premarket notification filed by Ultimed Incorporated with the FDA for Ulticare Safety Syringe With Removable Needle.

Pre-market Notification Details

Device IDK140949
510k NumberK140949
Device Name:ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLE
ClassificationSyringe, Antistick
Applicant ULTIMED INCORPORATED 5353 WAYZATA BLVD., SUITE 505 Minneapolis,  MN  55416
ContactMary Beth Henderson
CorrespondentMary Beth Henderson
ULTIMED INCORPORATED 5353 WAYZATA BLVD., SUITE 505 Minneapolis,  MN  55416
Product CodeMEG  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-04-14
Decision Date2015-02-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800117132586 K140949 000
08800117132517 K140949 000
08800117132319 K140949 000
08800117132234 K140949 000
08800117132210 K140949 000
08800117132135 K140949 000

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