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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 K904106
Device Name SPA SHELL
Applicant
Century Manufacturing Co.
P.O. Box C
Industrial Park
Aurora,  IL  68818
Applicant Contact KATHY KUHLENENGEL
Correspondent
Century Manufacturing Co.
P.O. Box C
Industrial Park
Aurora,  IL  68818
Correspondent Contact KATHY KUHLENENGEL
Regulation Number890.5100
Classification Product Code
ILJ  
Date Received09/06/1990
Decision Date 09/18/1990
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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