The following data is part of a premarket notification filed by Inpharma A.s. with the FDA for Caphosol Artificial Saliva.
| Device ID | K991938 |
| 510k Number | K991938 |
| Device Name: | CAPHOSOL ARTIFICIAL SALIVA |
| Classification | Saliva, Artificial |
| Applicant | INPHARMA A.S. P.O. BOX 809, 27 SOUTH ST. Northborough, MA 01532 |
| Contact | Bruce R Manning |
| Correspondent | Bruce R Manning INPHARMA A.S. P.O. BOX 809, 27 SOUTH ST. Northborough, MA 01532 |
| 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 | 1999-06-09 |
| Decision Date | 1999-08-10 |
| Summary: | summary |