The following data is part of a premarket notification filed by Surgipath Medical Industries, Inc. with the FDA for Polystat, Biological Stain.
| Device ID | K844640 |
| 510k Number | K844640 |
| Device Name: | POLYSTAT, BIOLOGICAL STAIN |
| Classification | Toluidine Blue |
| Applicant | SURGIPATH MEDICAL INDUSTRIES, INC. P.O. BOX 769 Grayslake, IL 60030 |
| Contact | Ken Urban |
| Correspondent | Ken Urban SURGIPATH MEDICAL INDUSTRIES, INC. P.O. BOX 769 Grayslake, IL 60030 |
| Product Code | IAB |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-28 |
| Decision Date | 1985-01-30 |