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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Bath, Hydro-Massage
510(k) Number K811904
Device Name CENTURY HYDRO-SAN THERAPY TANK
Applicant
Century Manufacturing Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Century Manufacturing Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number890.5100
Classification Product Code
ILJ  
Date Received07/01/1981
Decision Date 07/20/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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