ULTICARE DISPOSABLE SYRINGES AND NEEDLES

Syringe, Piston

ULTIMED, INC.

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

Pre-market Notification Details

Device IDK062702
510k NumberK062702
Device Name:ULTICARE DISPOSABLE SYRINGES AND NEEDLES
ClassificationSyringe, Piston
Applicant ULTIMED, INC. 5353 WAYZATA BLVD. SUITE 505 Minneapolis,  MN  55416 -1334
ContactCarole Stamp
CorrespondentCarole Stamp
ULTIMED, INC. 5353 WAYZATA BLVD. SUITE 505 Minneapolis,  MN  55416 -1334
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-09-11
Decision Date2006-11-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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