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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 K941610
Device Name CLENSICAIR LOW AIRLOSS HYDROTHERAPY
Applicant
Support Systems Intl.
4349 Corporate Rd.
Charleston,  SC  29405
Applicant Contact THOMAS MCFADDEN
Correspondent
Support Systems Intl.
4349 Corporate Rd.
Charleston,  SC  29405
Correspondent Contact THOMAS MCFADDEN
Regulation Number890.5170
Classification Product Code
IOQ  
Date Received03/31/1994
Decision Date 02/10/1995
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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