The following data is part of a premarket notification filed by Surgipath with the FDA for 10% Neutral Buffered Formalin Concent.
| Device ID | K812940 |
| 510k Number | K812940 |
| Device Name: | 10% NEUTRAL BUFFERED FORMALIN CONCENT |
| Classification | Formalin, Neutral Buffered |
| Applicant | SURGIPATH 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IFP |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-20 |
| Decision Date | 1981-12-10 |