The following data is part of a premarket notification filed by Tatung Company Of America, Inc. with the FDA for Ultrasonic Denture Cleaner.
| Device ID | K881391 |
| 510k Number | K881391 |
| Device Name: | ULTRASONIC DENTURE CLEANER |
| Classification | Cleaner, Denture, Mechanical |
| 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 | JER |
| CFR Regulation Number | 872.3530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-04 |
| Decision Date | 1988-08-26 |