NATRELLE INSPIRA Single Use Sizers for Gel Implants
FDA 510(k) clearance K203229 · decided 2021-06-02
Clearance details
- K-number
- K203229
- Device name
- NATRELLE INSPIRA Single Use Sizers for Gel Implants
- Applicant
- Allergan
- Decision
- Substantially Equivalent
- Date received
- 2020-11-02
- Decision date
- 2021-06-02
- Days to decision
- 212 days
- Clearance type
- Special
- Product code
- MRD
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.