HYPOSERMIC NEEDLES

Needle, Hypodermic, Single Lumen

OPTICAL MICRO SYSTEMS, INC.

The following data is part of a premarket notification filed by Optical Micro Systems, Inc. with the FDA for Hyposermic Needles.

Pre-market Notification Details

Device IDK813545
510k NumberK813545
Device Name:HYPOSERMIC NEEDLES
ClassificationNeedle, Hypodermic, Single Lumen
Applicant OPTICAL MICRO SYSTEMS, 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 Received1981-12-21
Decision Date1982-01-12

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