The following data is part of a premarket notification filed by Roxane Laboratories, Inc. with the FDA for Saliva Substitute.
| Device ID | K822971 |
| 510k Number | K822971 |
| Device Name: | SALIVA SUBSTITUTE |
| Classification | Saliva, Artificial |
| Applicant | ROXANE LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LFD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-08 |
| Decision Date | 1982-11-16 |