Name: Predicase
Price: 199 USD

K-number	K082677
Device name	AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
Applicant	American Medical Systems, Inc.
Product code	OTP
Device class	Class III
Decision date	Dec 23, 2008
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 ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

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