K-number	K910305
Device name	GEM-PREMIER SYSTEM
Applicant	Mallinckrodt Sensor Systems, Inc.
Product code	JGS
Device class	Class II
Decision date	Apr 3, 1991
Decision	Substantially Equivalent
Regulation	862.1665

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View the full FDA submission: accessdata.fda.gov

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GEM-PREMIER SYSTEM

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