DISPOSABLE HYPODERMIC NEEDLES

Needle, Hypodermic, Single Lumen

MEDCARE DISP PRODUCTS, INC.

The following data is part of a premarket notification filed by Medcare Disp Products, Inc. with the FDA for Disposable Hypodermic Needles.

Pre-market Notification Details

Device IDK821529
510k NumberK821529
Device Name:DISPOSABLE HYPODERMIC NEEDLES
ClassificationNeedle, Hypodermic, Single Lumen
Applicant MEDCARE DISP PRODUCTS, 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 Received1982-05-21
Decision Date1982-06-09

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