K-number	K173779
Device name	REXMONO, PDREX
Applicant	Sm Eng Co., Ltd.
Product code	GAM
Device class	Class II
Decision date	Mar 12, 2018
Decision	Substantially Equivalent
Regulation	878.4493

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View the full FDA submission: accessdata.fda.gov

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REXMONO, PDREX

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