The following data is part of a premarket notification filed by E K Ind., Inc. with the FDA for Saline, 0.85%w/preservative.
| Device ID | K842725 |
| 510k Number | K842725 |
| Device Name: | SALINE, 0.85%W/PRESERVATIVE |
| Classification | Formulations, Balanced Salt Solutions |
| Applicant | E K IND., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KIP |
| CFR Regulation Number | 864.2875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-13 |
| Decision Date | 1984-08-03 |