MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER
FDA 510(k) clearance K062421 · decided 2006-10-10
Clearance details
- K-number
- K062421
- Device name
- MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER
- Applicant
- Mentor Corporation
- Decision
- Substantially Equivalent
- Date received
- 2006-08-18
- Decision date
- 2006-10-10
- Days to decision
- 53 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
| Record | Firm | Date |
|---|---|---|
| MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis recall (Z-0964-2015) | Mentor Texas, LP. | 2015-01-13 |