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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Air Fluidized
510(k) Number K964223
Device Name CLINITRON RITE-HITE
Applicant
Hill-Rom, Inc.
4349 Corporate Rd.
Charleston,  SC  29405
Applicant Contact EDWIN HILLS
Correspondent
Hill-Rom, Inc.
4349 Corporate Rd.
Charleston,  SC  29405
Correspondent Contact EDWIN HILLS
Regulation Number890.5160
Classification Product Code
INX  
Date Received10/23/1996
Decision Date 05/28/1997
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
Recalls CDRH Recalls
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