The following data is part of a premarket notification filed by Biocosmetics Laboratories with the FDA for Air Lift/xerostom Artificial Saliva.
Device ID | K120552 |
510k Number | K120552 |
Device Name: | AIR LIFT/XEROSTOM ARTIFICIAL SALIVA |
Classification | Saliva, Artificial |
Applicant | BIOCOSMETICS LABORATORIES 57 LAZY BROOK RD Monroe, CT 06468 |
Contact | Ray Kelly |
Correspondent | Ray Kelly BIOCOSMETICS LABORATORIES 57 LAZY BROOK RD Monroe, CT 06468 |
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 | 2012-02-23 |
Decision Date | 2012-06-06 |