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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tissue Expander And Accessories
510(k) Number K214124
Device Name AlloX2 Pro Tissue Expanders
Applicant
Sientra, Inc.
420 S. Fairview Ave.
Suite 200
Santa Barbara,  CA  93117
Applicant Contact Denise Daljes
Correspondent
Sientra, Inc.
420 S. Fairview Ave.
Suite 200
Santa Barbara,  CA  93117
Correspondent Contact Denise Daljes
Classification Product Code
LCJ  
Date Received12/30/2021
Decision Date 06/08/2023
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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