The following data is part of a premarket notification filed by Remel Co. with the FDA for Saf Fixative.
| Device ID | K803054 |
| 510k Number | K803054 |
| Device Name: | SAF FIXATIVE |
| Classification | Solution, Formalin-sodium Acetate |
| Applicant | REMEL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IGB |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-02 |
| Decision Date | 1980-12-22 |