The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Accu-tec System For Tissue Expander Injection Port.
| Device ID | K905484 |
| 510k Number | K905484 |
| Device Name: | ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT |
| Classification | Expander, Skin, Inflatable |
| Applicant | MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
| Contact | Bryon H Wickett |
| Correspondent | Bryon H Wickett 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 | 1990-12-06 |
| Decision Date | 1991-02-11 |