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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Flotation Therapy, Powered
510(k) Number K901890
Device Name MARK IV FLOATATION THERAPY BED
Applicant
Hydrothermic Floatation Systems, Inc.
6404 Hollywood Blvd.
Suite 225
Los Angeles,  CA  90028
Applicant Contact M. C BALLOU-HANSEN
Correspondent
Hydrothermic Floatation Systems, Inc.
6404 Hollywood Blvd.
Suite 225
Los Angeles,  CA  90028
Correspondent Contact M. C BALLOU-HANSEN
Regulation Number890.5170
Classification Product Code
IOQ  
Date Received04/26/1990
Decision Date 05/07/1990
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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