DISP. HYPODERMIC NEEDLE

Needle, Hypodermic, Single Lumen

TERUMO AMERICA, INC.

The following data is part of a premarket notification filed by Terumo America, Inc. with the FDA for Disp. Hypodermic Needle.

Pre-market Notification Details

Device IDK771203
510k NumberK771203
Device Name:DISP. HYPODERMIC NEEDLE
ClassificationNeedle, Hypodermic, Single Lumen
Applicant TERUMO AMERICA, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-07-05
Decision Date1977-07-14

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