The following data is part of a premarket notification filed by Surgipath Medical Industries, Inc. with the FDA for Neutral Buffered Formalin 10%.
| Device ID | K830583 |
| 510k Number | K830583 |
| Device Name: | NEUTRAL BUFFERED FORMALIN 10% |
| Classification | Formalin, Neutral Buffered |
| Applicant | SURGIPATH MEDICAL INDUSTRIES, INC. 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 | 1983-02-23 |
| Decision Date | 1983-03-17 |