The following data is part of a premarket notification filed by Anatech, Ltd. with the FDA for Cb Formalin.
| Device ID | K842862 |
| 510k Number | K842862 |
| Device Name: | CB FORMALIN |
| Classification | Solution, Formalin Ammonium Bromide |
| Applicant | ANATECH, LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IGE |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-23 |
| Decision Date | 1984-08-28 |