K-number	K972093
Device name	REGENESIS MODEL 42
Applicant	Regenesis Biomedical, Inc.
Product code	ILX
Device class	Class II
Decision date	Oct 21, 1997
Decision	Substantially Equivalent
Regulation	890.5290

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View the full FDA submission: accessdata.fda.gov

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REGENESIS MODEL 42

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