The following data is part of a premarket notification filed by Applied Biomaterial Technologies with the FDA for Zymalar Implant.
| Device ID | K902284 |
| 510k Number | K902284 |
| Device Name: | ZYMALAR IMPLANT |
| Classification | Implant, Malar |
| Applicant | APPLIED BIOMATERIAL TECHNOLOGIES 851 SIXTH ST. S#145 Bremerton, WA 98310 |
| Contact | L Hanson |
| Correspondent | L Hanson APPLIED BIOMATERIAL TECHNOLOGIES 851 SIXTH ST. S#145 Bremerton, WA 98310 |
| Product Code | LZK |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-22 |
| Decision Date | 1990-09-12 |