AeroForm Tissue Expander, Smooth— 510(k) K191138

Substantially Equivalent

Airxpanders, Inc.

FDA 510(k) clearance K191138 for AeroForm Tissue Expander, Smooth, Substantially Equivalent on 2019-07-11. Applicant: Airxpanders, Inc..

Clearance details

Applicant
Airxpanders, Inc.
Product code
Code PQN
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
San Jose, CA, US
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