Name: Predicase
Price: 199 USD

K-number	K122459
Device name	PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM
Applicant	Boston Scientific Corporation
Product code	OTP
Device class	Class III
Decision date	Dec 13, 2012
Decision	Substantially Equivalent
Regulation	884.5980

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Source

View the full FDA submission: accessdata.fda.gov

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PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM

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