K-number	K201400
Device name	npSIMS Negative Pressure Surgical Incision Management System (npSIMS)
Applicant	Aatru Medical, LLC
Product code	QPX
Device class	Class II
Decision date	Aug 23, 2021
Decision	Substantially Equivalent
Regulation	878.4683

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Source

View the full FDA submission: accessdata.fda.gov

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npSIMS Negative Pressure Surgical Incision Management System (npSIMS)

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npSIMS Negative Pressure Surgical Incision Management System (npSIMS)