K-number	K904103
Device name	SEP 90
Applicant	Elema-Schonander, Inc.
Product code	IZP
Device class	Class II
Decision date	Nov 20, 1990
Decision	Substantially Equivalent
Regulation	892.1870

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View the full FDA submission: accessdata.fda.gov

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SEP 90

Everything you need for a 510(k) submission. Nothing you don't.