The following data is part of a premarket notification filed by Surgipath Medical Industries, Inc. with the FDA for Formaldehyde Solution, 37%.
| Device ID | K861201 |
| 510k Number | K861201 |
| Device Name: | FORMALDEHYDE SOLUTION, 37% |
| Classification | Formaldehyde (formalin, Formol) |
| Applicant | SURGIPATH MEDICAL INDUSTRIES, INC. P.O. BOX 769 Grayslake, IL 60030 |
| Contact | Urban, Ht |
| Correspondent | Urban, Ht SURGIPATH MEDICAL INDUSTRIES, INC. P.O. BOX 769 Grayslake, IL 60030 |
| Product Code | IGG |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-31 |
| Decision Date | 1986-04-11 |