Name: Predicase
Price: 199 USD

K-number	K213853
Device name	RENASYS-WF White Foam NPWT Dressing Small; RENASYS-WF White Foam NPWT Dressing Large
Applicant	Smith and Nephew Medical Limited
Product code	OMP
Device class	Class II
Decision date	Feb 10, 2023
Decision	Substantially Equivalent
Regulation	878.4780

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Source

View the full FDA submission: accessdata.fda.gov

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RENASYS-WF White Foam NPWT Dressing Small; RENASYS-WF White Foam NPWT Dressing Large

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

RENASYS-WF White Foam NPWT Dressing Small; RENASYS-WF White Foam NPWT Dressing Large