The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Sterile Saline Mammary Volume Sizers.
| Device ID | K010709 |
| 510k Number | K010709 |
| Device Name: | MENTOR STERILE SALINE MAMMARY VOLUME SIZERS |
| Classification | Sizer, Mammary, Breast Implant Volume |
| Applicant | MENTOR CORP. 201 MENTOR DR. Santa Barbara, CA 93111 |
| Contact | Donna Crawford |
| Correspondent | Donna Crawford MENTOR CORP. 201 MENTOR DR. 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 | 2001-03-09 |
| Decision Date | 2001-04-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00081317002604 | K010709 | 000 |
| 00081317002727 | K010709 | 000 |
| 00081317002734 | K010709 | 000 |
| 00081317002741 | K010709 | 000 |
| 00081317002758 | K010709 | 000 |
| 00081317002765 | K010709 | 000 |
| 00081317002772 | K010709 | 000 |
| 00081317002789 | K010709 | 000 |
| 00081317002796 | K010709 | 000 |
| 00081317002710 | K010709 | 000 |
| 00081317002703 | K010709 | 000 |
| 00081317002697 | K010709 | 000 |
| 00081317002611 | K010709 | 000 |
| 00081317002628 | K010709 | 000 |
| 00081317002635 | K010709 | 000 |
| 00081317002642 | K010709 | 000 |
| 00081317002659 | K010709 | 000 |
| 00081317002666 | K010709 | 000 |
| 00081317002673 | K010709 | 000 |
| 00081317002680 | K010709 | 000 |
| 00081317002802 | K010709 | 000 |
| 00081317002819 | K010709 | 000 |
| 00081317002826 | K010709 | 000 |
| 00081317002949 | K010709 | 000 |
| 00081317002956 | K010709 | 000 |
| 00081317002963 | K010709 | 000 |
| 00081317002970 | K010709 | 000 |
| 00081317002987 | K010709 | 000 |
| 00081317002994 | K010709 | 000 |
| 00081317003007 | K010709 | 000 |
| 00081317003014 | K010709 | 000 |
| 00081317002932 | K010709 | 000 |
| 00081317002925 | K010709 | 000 |
| 00081317002918 | K010709 | 000 |
| 00081317002833 | K010709 | 000 |
| 00081317002840 | K010709 | 000 |
| 00081317002857 | K010709 | 000 |
| 00081317002864 | K010709 | 000 |
| 00081317002871 | K010709 | 000 |
| 00081317002888 | K010709 | 000 |
| 00081317002895 | K010709 | 000 |
| 00081317002901 | K010709 | 000 |
| 00081317003021 | K010709 | 000 |