Name: Predicase
Price: 199 USD

K-number	K082387
Device name	APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM
Applicant	American Medical Systems
Product code	OTP
Device class	Class III
Decision date	Dec 4, 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 INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM

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