STERILE INSULIN DISPOS. NEEDLE/GREEN

Syringe, Piston

LEE MEDICAL INTL., INC.

The following data is part of a premarket notification filed by Lee Medical Intl., Inc. with the FDA for Sterile Insulin Dispos. Needle/green.

Pre-market Notification Details

Device IDK840083
510k NumberK840083
Device Name:STERILE INSULIN DISPOS. NEEDLE/GREEN
ClassificationSyringe, Piston
Applicant LEE MEDICAL INTL., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-01-10
Decision Date1984-02-21

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