The following data is part of a premarket notification filed by Century Manufacturing Co. with the FDA for Spa Shell.
| Device ID | K904106 |
| 510k Number | K904106 |
| Device Name: | SPA SHELL |
| Classification | Bath, Hydro-massage |
| Applicant | CENTURY MANUFACTURING CO. P.O. BOX C INDUSTRIAL PARK Aurora, IL 68818 |
| Contact | Kathy Kuhlenengel |
| Correspondent | Kathy Kuhlenengel CENTURY MANUFACTURING CO. P.O. BOX C INDUSTRIAL PARK Aurora, IL 68818 |
| Product Code | ILJ |
| CFR Regulation Number | 890.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-06 |
| Decision Date | 1990-09-18 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SPA SHELL 74275979 1889782 Dead/Cancelled |
Arjo, Inc. 1992-05-18 |