The following data is part of a premarket notification filed by Cui Corp. with the FDA for Cui Anatomical Silicone Malar.
| Device ID | K903329 |
| 510k Number | K903329 |
| Device Name: | CUI ANATOMICAL SILICONE MALAR |
| Classification | Implant, Malar |
| Applicant | CUI CORP. P.O. BOX 40288 Santa Barbara, CA 93140 |
| Contact | Morris Sherwood |
| Correspondent | Morris Sherwood CUI CORP. P.O. BOX 40288 Santa Barbara, CA 93140 |
| Product Code | LZK |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-25 |
| Decision Date | 1990-09-10 |