AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5)— 510(k) K170075

Name: FDA 510(k) clearance K170075
Creator: U.S. Food and Drug Administration
Published: 2017-04-03

Substantially Equivalent

Airxpanders, Inc.

FDA 510(k) clearance K170075 for AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5), Substantially Equivalent on 2017-04-03. Applicant: Airxpanders, Inc..

Clearance details

Applicant: Airxpanders, Inc.
Product code: Code PQN
Advisory panel: General, Plastic Surgery
Date received: 2017-01-09
Decision date: 2017-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, US

Download summary PDF View on FDA.gov ↗

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