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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Ac-Powered Adjustable Hospital
510(k) Number K843781
Device Name KINAIR, LOW AIR LOSS BED
Applicant
Kinetic Concepts, Inc.
3417 Steen Dr.
San Antonio,  TX  78219
Applicant Contact ROBERT A WEHRMEYER
Correspondent
Kinetic Concepts, Inc.
3417 Steen Dr.
San Antonio,  TX  78219
Correspondent Contact ROBERT A WEHRMEYER
Regulation Number880.5100
Classification Product Code
FNL  
Date Received09/26/1984
Decision Date 01/28/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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