The following data is part of a premarket notification filed by I M, Inc. with the FDA for Sterile Saline Solution.
| Device ID | K854155 |
| 510k Number | K854155 |
| Device Name: | STERILE SALINE SOLUTION |
| Classification | Lubricant, Patient |
| Applicant | I M, INC. P.O. BOX 658 Fairfield, NJ 07004 |
| Contact | Amir Porat |
| Correspondent | Amir Porat I M, INC. P.O. BOX 658 Fairfield, NJ 07004 |
| Product Code | KMJ |
| CFR Regulation Number | 880.6375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-11 |
| Decision Date | 1985-12-10 |