Name: Predicase
Price: 199 USD

K-number	K090713
Device name	ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP
Applicant	American Medical Systems, Inc.
Product code	OTP
Device class	Class III
Decision date	Apr 2, 2009
Decision	Substantially Equivalent
Regulation	884.5980

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Source

View the full FDA submission: accessdata.fda.gov

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ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP

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