K-number	K172197
Device name	SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS
Applicant	Origio A/S
Product code	MQL
Device class	Class II
Decision date	Oct 13, 2017
Decision	Substantially Equivalent
Regulation	884.6180

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Source

View the full FDA submission: accessdata.fda.gov

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SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS

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