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510(k) K191138

Device
AeroForm Tissue Expander, Smooth
Applicant
AirXpanders, Inc.
510(k) number
K191138
Product code
PQN  
Decision
Substantially Equivalent (SESE)
Decision date
2019-07-11
Date received
2019-04-30
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
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Belinda Pinedo
Address
3047 Orchard Pkwy. San Jose CA US 95134 95134

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
K170075AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5)Airxpanders, Inc.2017-04-03
DEN150055AeroForm Tissue Expander SystemAirxpanders, Inc.2016-12-21

Legacy Summary#

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FDA Review#

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