K-number	K081710
Device name	APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE
Applicant	American Medical Systems
Product code	OTP
Device class	Class III
Decision date	Oct 15, 2008
Decision	Substantially Equivalent
Regulation	884.5980

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Source

View the full FDA submission: accessdata.fda.gov

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APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE

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