Name: Predicase
Price: 199 USD

K-number	K161897
Device name	PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings
Applicant	Kci USA, Inc. (Kinetic Concepts, Inc.)
Product code	OMP
Device class	Class II
Decision date	Oct 4, 2016
Decision	Substantially Equivalent
Regulation	878.4780

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Source

View the full FDA submission: accessdata.fda.gov

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PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings

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