K-number	K973373
Device name	PREVENT I
Applicant	The Buzzz Corp.
Product code	INO
Device class	Class II
Decision date	Feb 26, 1998
Decision	Substantially Equivalent
Regulation	890.3110

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Source

View the full FDA submission: accessdata.fda.gov

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PREVENT I

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