510(k) K811903

CENTURY HYDROTHERAPY PUMP by Century Manufacturing Co. — Product Code ILJ

K811903 is an FDA 510(k) premarket notification submitted by Century Manufacturing Co. for the device "CENTURY HYDROTHERAPY PUMP". The FDA issued a decision of Substantially Equivalent on July 20, 1981. The device falls under product code ILJ (Bath, Hydro-Massage), a Class II device regulated under 21 CFR 890.5100. Century Manufacturing Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1981
Date Received
July 1, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bath, Hydro-Massage
Device Class
Class II
Regulation Number
890.5100
Review Panel
PM
Submission Type