DeviceClearance

Sientra OPUS Silicone Gel Breast Implant Sizer— 510(k) K200706

Substantially Equivalent

Sientra, Inc.

FDA 510(k) clearance K200706 for Sientra OPUS Silicone Gel Breast Implant Sizer, Substantially Equivalent on 2020-11-16. Applicant: Sientra, Inc..

Clearance details

Applicant
Sientra, Inc.
Product code
Code MRD
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Santa Barbara, CA, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.