Name: Predicase
Price: 199 USD

K-number	K211318
Device name	PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs
Applicant	Smith Nephew Medical Limited
Product code	OMP
Device class	Class II
Decision date	Jan 5, 2022
Decision	Substantially Equivalent
Regulation	878.4780

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Source

View the full FDA submission: accessdata.fda.gov

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PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs

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