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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 K890548
Device Name AQUACISER SYSTEM
Applicant
Aquaciser, Inc.
333 W. Wacker Dr.
Suite 1900
Chicago,  IL  60606
Applicant Contact THOMAS J MULDOON
Correspondent
Aquaciser, Inc.
333 W. Wacker Dr.
Suite 1900
Chicago,  IL  60606
Correspondent Contact THOMAS J MULDOON
Regulation Number890.5100
Classification Product Code
ILJ  
Date Received02/03/1989
Decision Date 02/13/1989
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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