NEONATAL LUMBAR PUNCTURE TRAY

Needle, Hypodermic, Single Lumen

AMERICAN PHARMASEAL DIV. AHSC

The following data is part of a premarket notification filed by American Pharmaseal Div. Ahsc with the FDA for Neonatal Lumbar Puncture Tray.

Pre-market Notification Details

Device IDK832556
510k NumberK832556
Device Name:NEONATAL LUMBAR PUNCTURE TRAY
ClassificationNeedle, Hypodermic, Single Lumen
Applicant AMERICAN PHARMASEAL DIV. AHSC 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 Received1983-08-01
Decision Date1983-09-12

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