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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 K912855
Device Name HAZEL
Applicant
KINETIC CONCEPTS, INC.
P.O. BOX 8588
SAN ANTONIO,  TX  78208
Applicant Contact WILLIAM H QUIRK
Correspondent
KINETIC CONCEPTS, INC.
P.O. BOX 8588
SAN ANTONIO,  TX  78208
Correspondent Contact WILLIAM H QUIRK
Regulation Number890.5170
Classification Product Code
IOQ  
Date Received06/28/1991
Decision Date 09/06/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
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