INFANT CARE SYSTEM

Needle, Hypodermic, Single Lumen

NARCO SCIENTIFIC

The following data is part of a premarket notification filed by Narco Scientific with the FDA for Infant Care System.

Pre-market Notification Details

Device IDK823899
510k NumberK823899
Device Name:INFANT CARE SYSTEM
ClassificationNeedle, Hypodermic, Single Lumen
Applicant NARCO SCIENTIFIC 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 Received1982-12-27
Decision Date1983-04-14

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