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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name carbon dioxide gas controlled tissue expander
510(k) Number K191138
Device Name AeroForm Tissue Expander, Smooth
Applicant
AirXpanders, Inc.
3047 Orchard Parkway
San Jose,  CA  95134
Applicant Contact Belinda Pinedo
Correspondent
AirXpanders, Inc.
3047 Orchard Parkway
San Jose,  CA  95134
Correspondent Contact Belinda Pinedo
Regulation Number878.3510
Classification Product Code
PQN  
Date Received04/30/2019
Decision Date 07/11/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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