The following data is part of a premarket notification filed by Inpharma A.s. with the FDA for Caphosol.
| Device ID | K030802 |
| 510k Number | K030802 |
| Device Name: | CAPHOSOL |
| Classification | Saliva, Artificial |
| Applicant | INPHARMA A.S. 96 WEST MAIN ST. Northborough, MA 01532 |
| Contact | Bruce Manning |
| Correspondent | Bruce Manning INPHARMA A.S. 96 WEST MAIN 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 | 2003-03-13 |
| Decision Date | 2003-11-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060146291576 | K030802 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CAPHOSOL 75092944 2487745 Live/Registered |
EUSA PHARMA (USA), INC. 1996-04-23 |