K-number	DEN150055
Device name	AeroForm Tissue Expander System
Applicant	Airxpanders, Inc.
Product code	PQN
Device class	Class II
Decision date	Dec 21, 2016
Decision	Not Substantially Equivalent
Regulation	878.3510

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View the full FDA submission: accessdata.fda.gov

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AeroForm Tissue Expander System

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