The following data is part of a premarket notification filed by Surgipath with the FDA for Orange G-6.
| Device ID | K811825 |
| 510k Number | K811825 |
| Device Name: | ORANGE G-6 |
| Classification | Orange G |
| Applicant | SURGIPATH 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HZH |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-29 |
| Decision Date | 1981-07-10 |