K-number	K942677
Device name	GEENEN/ZEBRA GUIDELINES
Applicant	Boston Scientific Corp
Product code	FDE
Device class	Class II
Decision date	Jul 21, 1994
Decision	Substantially Equivalent
Regulation	876.1500

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View the full FDA submission: accessdata.fda.gov

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GEENEN/ZEBRA GUIDELINES

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