ULTI GUARD HOME INSULIN SYRINGE CONTAINER

Container, Sharps

ULTI MED, INC.

The following data is part of a premarket notification filed by Ulti Med, Inc. with the FDA for Ulti Guard Home Insulin Syringe Container.

Pre-market Notification Details

Device IDK021983
510k NumberK021983
Device Name:ULTI GUARD HOME INSULIN SYRINGE CONTAINER
ClassificationContainer, Sharps
Applicant ULTI MED, INC. 287 EAST SIXTH ST. St. Paul,  MN  55101
ContactCharles W Erickson
CorrespondentCharles W Erickson
ULTI MED, INC. 287 EAST SIXTH ST. St. Paul,  MN  55101
Product CodeMMK  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-06-18
Decision Date2002-09-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20357515093558 K021983 000
20357515093350 K021983 000
20357515094593 K021983 000
20357515094395 K021983 000
20357515094197 K021983 000

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