The following data is part of a premarket notification filed by Volu Sol Medical Industries with the FDA for Volu-sol Zenkers Fixative.
| Device ID | K822127 |
| 510k Number | K822127 |
| Device Name: | VOLU-SOL ZENKERS FIXATIVE |
| Classification | Solution, Zenker's |
| Applicant | VOLU SOL MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IFH |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-19 |
| Decision Date | 1982-08-05 |