The following data is part of a premarket notification filed by Tatung Company Of America, Inc. with the FDA for Tatung's Denture Cleaning Solution.
Device ID | K874805 |
510k Number | K874805 |
Device Name: | TATUNG'S DENTURE CLEANING SOLUTION |
Classification | Cleanser, Denture, Over The Counter |
Applicant | TATUNG COMPANY OF AMERICA, INC. 2850 EL PRESIDIO ST. Long Beach, CA 90810 |
Contact | Julia Cassidy |
Correspondent | Julia Cassidy TATUNG COMPANY OF AMERICA, INC. 2850 EL PRESIDIO ST. Long Beach, CA 90810 |
Product Code | EFT |
CFR Regulation Number | 872.3520 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-23 |
Decision Date | 1988-02-16 |