The following data is part of a premarket notification filed by Mentor Corporation with the FDA for Mentor Resterilizable Gel Breast Implant Sizer.
Device ID | K062421 |
510k Number | K062421 |
Device Name: | MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER |
Classification | Sizer, Mammary, Breast Implant Volume |
Applicant | MENTOR CORPORATION 201 MENTOR DRIVE Santa Barbara, CA 93111 |
Contact | Nicola Selley |
Correspondent | Nicola Selley MENTOR CORPORATION 201 MENTOR DRIVE Santa Barbara, CA 93111 |
Product Code | MRD |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-08-18 |
Decision Date | 2006-10-10 |
Summary: | summary |