The following data is part of a premarket notification filed by Hardy Media with the FDA for Sterile Saline 0.85%.
| Device ID | K834315 |
| 510k Number | K834315 |
| Device Name: | STERILE SALINE 0.85% |
| Classification | Culture Media, Non-propagating Transport |
| Applicant | HARDY MEDIA 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JSM |
| CFR Regulation Number | 866.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-09 |
| Decision Date | 1984-01-13 |