The following data is part of a premarket notification filed by Century Manufacturing Co. with the FDA for Century Hydro-san Therapy Tank.
Device ID | K811904 |
510k Number | K811904 |
Device Name: | CENTURY HYDRO-SAN THERAPY TANK |
Classification | Bath, Hydro-massage |
Applicant | CENTURY MANUFACTURING CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | ILJ |
CFR Regulation Number | 890.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-07-01 |
Decision Date | 1981-07-20 |