K-number	K003882
Device name	NUCAMMA BI90
Applicant	Is2 Research, Inc.
Product code	KPS
Device class	Class II
Decision date	Feb 21, 2001
Decision	Substantially Equivalent
Regulation	892.1200

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View the full FDA submission: accessdata.fda.gov

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NUCAMMA BI90

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