The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Cpx 4 Breast Tissue Expanders And Mentor Cpx 4 With Suture Tabs Breast Tissue Expanders.
| Device ID | K130813 |
| 510k Number | K130813 |
| Device Name: | MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS |
| Classification | Expander, Skin, Inflatable |
| Applicant | MENTOR CORP. 201 MENTOR DR. Santa Barbara, CA 93111 |
| Contact | Martin Sprunck |
| Correspondent | Martin Sprunck MENTOR CORP. 201 MENTOR DR. Santa Barbara, CA 93111 |
| Product Code | LCJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-25 |
| Decision Date | 2013-04-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00081317006831 | K130813 | 000 |
| 00081317006633 | K130813 | 000 |
| 00081317006626 | K130813 | 000 |
| 00081317006619 | K130813 | 000 |
| 00081317006602 | K130813 | 000 |
| 00081317006596 | K130813 | 000 |
| 00081317006589 | K130813 | 000 |
| 00081317006572 | K130813 | 000 |
| 00081317006565 | K130813 | 000 |
| 00081317006558 | K130813 | 000 |
| 00081317006541 | K130813 | 000 |
| 00081317006534 | K130813 | 000 |
| 00081317006527 | K130813 | 000 |
| 00081317006510 | K130813 | 000 |
| 00081317006503 | K130813 | 000 |
| 00081317006497 | K130813 | 000 |
| 00081317006480 | K130813 | 000 |
| 00081317006473 | K130813 | 000 |
| 00081317006640 | K130813 | 000 |
| 00081317006657 | K130813 | 000 |
| 00081317006824 | K130813 | 000 |
| 00081317006817 | K130813 | 000 |
| 00081317006800 | K130813 | 000 |
| 00081317006794 | K130813 | 000 |
| 00081317006787 | K130813 | 000 |
| 00081317006770 | K130813 | 000 |
| 00081317006763 | K130813 | 000 |
| 00081317006756 | K130813 | 000 |
| 00081317006749 | K130813 | 000 |
| 00081317006732 | K130813 | 000 |
| 00081317006725 | K130813 | 000 |
| 00081317006718 | K130813 | 000 |
| 00081317006701 | K130813 | 000 |
| 00081317006695 | K130813 | 000 |
| 00081317006688 | K130813 | 000 |
| 00081317006671 | K130813 | 000 |
| 00081317006664 | K130813 | 000 |
| 00081317006466 | K130813 | 000 |