K-number	K172483
Device name	Kopac Sterile Needle
Applicant	Poonglim Pharmatech, Inc.
Product code	FMI
Device class	Class II
Decision date	Jun 21, 2018
Decision	Substantially Equivalent
Regulation	880.5570

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Source

View the full FDA submission: accessdata.fda.gov

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Kopac Sterile Needle

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