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 |