K-number	K012435
Device name	ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626
Applicant	Bausch & Lomb, Inc.
Product code	NGY
Device class	Class I
Decision date	Oct 2, 2001
Decision	Substantially Equivalent
Regulation	886.4350

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View the full FDA submission: accessdata.fda.gov

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ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626

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