Name: Predicase
Price: 199 USD

K-number	K111118
Device name	AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
Applicant	American Medical Systems
Product code	OTP
Device class	Class III
Decision date	Jul 1, 2011
Decision	Substantially Equivalent
Regulation	884.5980

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Source

View the full FDA submission: accessdata.fda.gov

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AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

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