The following data is part of a premarket notification filed by Century Manufacturing Co. with the FDA for Century Bathing System.
Device ID | K811901 |
510k Number | K811901 |
Device Name: | CENTURY BATHING SYSTEM |
Classification | Lift, Patient, Ac-powered |
Applicant | CENTURY MANUFACTURING CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FNG |
CFR Regulation Number | 880.5500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-07-01 |
Decision Date | 1981-07-23 |