The following data is part of a premarket notification filed by Spectral Visualization & Development, Inc. with the FDA for Quiescence.
| Device ID | K040330 |
| 510k Number | K040330 |
| Device Name: | QUIESCENCE |
| Classification | Masker, Tinnitus |
| Applicant | SPECTRAL VISUALIZATION & DEVELOPMENT, INC. 921 COLLEGE HILL RD. Fredericton, New Brunswick, CA E3b 6z9 |
| Contact | Dennis Woo |
| Correspondent | Dennis Woo SPECTRAL VISUALIZATION & DEVELOPMENT, INC. 921 COLLEGE HILL RD. Fredericton, New Brunswick, CA E3b 6z9 |
| Product Code | KLW |
| CFR Regulation Number | 874.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-11 |
| Decision Date | 2004-04-12 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() QUIESCENCE 78334919 2908727 Dead/Cancelled |
Quiescence, LLC 2003-12-02 |
![]() QUIESCENCE 75623768 2378798 Dead/Cancelled |
Neways, Inc. 1999-01-19 |
![]() QUIESCENCE 75525536 2295598 Dead/Cancelled |
Rathbun, Ronald W. 1998-07-27 |