K-number	K212652
Device name	Sterile Syringe with Fixed Safety Needle for Single Use
Applicant	Gemtier Medical (Shanghai), Inc.
Product code	MEG
Device class	Class II
Decision date	Mar 2, 2022
Decision	Substantially Equivalent
Regulation	880.5860

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View the full FDA submission: accessdata.fda.gov

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Sterile Syringe with Fixed Safety Needle for Single Use

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