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 |