The following data is part of a premarket notification filed by Omega Medical Diagnostics with the FDA for Sodium Hypochlorite 3%.
| Device ID | K831620 |
| 510k Number | K831620 |
| Device Name: | SODIUM HYPOCHLORITE 3% |
| Classification | General Purpose Reagent |
| Applicant | OMEGA MEDICAL DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | PPM |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-19 |
| Decision Date | 1983-07-28 |