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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 K964873
Device Name SILKAIR LOW AIRLOSS THERAPY
Applicant
Hill-Rom, Inc.
4349 Corporate Rd.
Charleston,  SC  29405
Applicant Contact EDWIN BILLS
Correspondent
Hill-Rom, Inc.
4349 Corporate Rd.
Charleston,  SC  29405
Correspondent Contact EDWIN BILLS
Regulation Number890.5170
Classification Product Code
IOQ  
Date Received12/05/1996
Decision Date 07/03/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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