The following data is part of a premarket notification filed by Mentor Worldwide Llc with the FDA for Mentor Memoryshape Resterilizable Gel Sizer.
| Device ID | K131853 |
| 510k Number | K131853 |
| Device Name: | MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER |
| Classification | Sizer, Mammary, Breast Implant Volume |
| Applicant | MENTOR WORLDWIDE LLC 201 MENTOR DRIVE Santa Barbara, CA 93111 |
| Contact | Manchi Cheung |
| Correspondent | Manchi Cheung MENTOR WORLDWIDE LLC 201 MENTOR DRIVE Santa Barbara, CA 93111 |
| Product Code | MRD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-21 |
| Decision Date | 2013-07-17 |
| Summary: | summary |