TrueCare Biomedix Tamper Evident Cap

Syringe, Piston

US Infusion Inc. D/B/A Truecare Biomedix-USA

The following data is part of a premarket notification filed by Us Infusion Inc. D/b/a Truecare Biomedix-usa with the FDA for Truecare Biomedix Tamper Evident Cap.

Pre-market Notification Details

Device IDK210818
510k NumberK210818
Device Name:TrueCare Biomedix Tamper Evident Cap
ClassificationSyringe, Piston
Applicant US Infusion Inc. D/B/A Truecare Biomedix-USA 6356 Manor Ln Ste 101 South Miami,  FL  33143
ContactAbbey Kramarz
CorrespondentAbbey Kramarz
US Infusion Inc. D/B/A Truecare Biomedix-USA 6356 Manor Ln Ste 101 South Miami,  FL  33143
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-18
Decision Date2021-09-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
40850789007657 K210818 000

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