Sientra OPUS Silicone Gel Breast Implant Sizer
FDA 510(k) clearance K200706 · decided 2020-11-16
Clearance details
- K-number
- K200706
- Device name
- Sientra OPUS Silicone Gel Breast Implant Sizer
- Applicant
- Sientra, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-03-18
- Decision date
- 2020-11-16
- Days to decision
- 243 days
- Clearance type
- Traditional
- Product code
- MRD
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Santa Barbara, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.