The following data is part of a premarket notification filed by Anatech, Ltd. with the FDA for Zinc Formalin.
| Device ID | K882874 |
| 510k Number | K882874 |
| Device Name: | ZINC FORMALIN |
| Classification | Fixative, Metallic Containing |
| Applicant | ANATECH, LTD. 1020 HARTS LAKE RD. Battle Creek, MI 49015 |
| Contact | Feldman, M.s. |
| Correspondent | Feldman, M.s. ANATECH, LTD. 1020 HARTS LAKE RD. Battle Creek, MI 49015 |
| Product Code | LDX |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-11 |
| Decision Date | 1988-07-28 |