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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mammary sizer
510(k) Number K200706
Device Name Sientra OPUS Silicone Gel Breast Implant Sizer
Applicant
Sientra, Inc
420 South Fairview Avenue, Suite 200
Santa Barbara,  CA  93117
Applicant Contact JoAnn Kuhne
Correspondent
Sientra, Inc
420 South Fairview Avenue, Suite 200
Santa Barbara,  CA  93117
Correspondent Contact JoAnn Kuhne
Classification Product Code
MRD  
Date Received03/18/2020
Decision Date 11/16/2020
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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