K-number	K191138
Device name	AeroForm Tissue Expander, Smooth
Applicant	Airxpanders, Inc.
Product code	PQN
Device class	Class II
Decision date	Jul 11, 2019
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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AeroForm Tissue Expander, Smooth

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