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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 K926402
Device Name COMFORT CARE LOW AIR LOSS THERAPY BED
Applicant
Ch Administration, Inc.
P.O. Box 29923
Dallas,  TX  75229
Applicant Contact JOHN A CARBONA
Correspondent
Ch Administration, Inc.
P.O. Box 29923
Dallas,  TX  75229
Correspondent Contact JOHN A CARBONA
Regulation Number890.5160
Classification Product Code
INX  
Date Received12/21/1992
Decision Date 03/24/1993
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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