Sterile Hypodermic Needles For Single Use

Needle, Hypodermic, Single Lumen

Azur Medical Company Inc.

The following data is part of a premarket notification filed by Azur Medical Company Inc. with the FDA for Sterile Hypodermic Needles For Single Use.

Pre-market Notification Details

Device IDK211214
510k NumberK211214
Device Name:Sterile Hypodermic Needles For Single Use
ClassificationNeedle, Hypodermic, Single Lumen
Applicant Azur Medical Company Inc. 6710 Everglades Dr. Richmond,  VA  23838
ContactDi Zhao
CorrespondentDi Zhao
Azur Medical Company Inc. 6710 Everglades Dr. Richmond,  VA  23838
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-23
Decision Date2021-10-14

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