K-number	K200706
Device name	Sientra OPUS Silicone Gel Breast Implant Sizer
Applicant	Sientra, Inc.
Product code	MRD
Device class	Class U
Decision date	Nov 16, 2020
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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Sientra OPUS Silicone Gel Breast Implant Sizer

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