Name: Predicase
Price: 199 USD

K-number	K153209
Device name	RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply
Applicant	Smith & Nephew Medical, Ltd.
Product code	OMP
Device class	Class II
Decision date	Aug 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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RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply

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