K-number	K944590
Device name	ETHICON DRILL BIT AND DRILL GUIDE
Applicant	ETHICON, Inc.
Product code	HSZ
Device class	Class I
Decision date	May 11, 1995
Decision	Substantially Equivalent
Regulation	878.4820

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View the full FDA submission: accessdata.fda.gov

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ETHICON DRILL BIT AND DRILL GUIDE

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