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510(k) K170075

Device
AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5)
Applicant
AirXpanders, Inc.
510(k) number
K170075
Product code
PQN  
Decision
Substantially Equivalent (SESE)
Decision date
2017-04-03
Date received
2017-01-09
Regulation
878.3510
Classification name
Carbon Dioxide Gas Controlled Tissue Expander
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Belinda Pinedo
Address
1047 Elwell Ct. Palo Alto CA US 94303 94303

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PQN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K191138AeroForm Tissue Expander, SmoothAirxpanders, Inc.2019-07-11
DEN150055AeroForm Tissue Expander SystemAirxpanders, Inc.2016-12-21

Legacy Summary#

summary

FDA Review#

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