Sterile Syringes For Single Use With/without Needle

Syringe, Piston

Azur Medical Company Inc.

The following data is part of a premarket notification filed by Azur Medical Company Inc. with the FDA for Sterile Syringes For Single Use With/without Needle.

Pre-market Notification Details

Device IDK211211
510k NumberK211211
Device Name:Sterile Syringes For Single Use With/without Needle
ClassificationSyringe, Piston
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 CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-23
Decision Date2021-10-07

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.