The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Tissue Expanders W/tdmac Coating.
| Device ID | K894475 |
| 510k Number | K894475 |
| Device Name: | MENTOR TISSUE EXPANDERS W/TDMAC COATING |
| Classification | Expander, Skin, Inflatable |
| Applicant | MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
| Contact | Terry A Thompson |
| Correspondent | Terry A Thompson MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
| Product Code | LCJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-18 |
| Decision Date | 1990-11-26 |