STERILE DISPOSABLE NEEDLES

Needle, Hypodermic, Single Lumen

LEE MEDICAL INTL., INC.

The following data is part of a premarket notification filed by Lee Medical Intl., Inc. with the FDA for Sterile Disposable Needles.

Pre-market Notification Details

Device IDK832102
510k NumberK832102
Device Name:STERILE DISPOSABLE NEEDLES
ClassificationNeedle, Hypodermic, Single Lumen
Applicant LEE MEDICAL INTL., 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 Received1983-06-23
Decision Date1983-09-01

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