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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mattress, Air Flotation, Alternating Pressure
510(k) Number K944094
Device Name TRIADYNE
Applicant
Kinetic Concepts, Inc.
P.O. Box 659508
San Antonio,  TX  78265
Applicant Contact WILLIAM H QUIRK
Correspondent
Kinetic Concepts, Inc.
P.O. Box 659508
San Antonio,  TX  78265
Correspondent Contact WILLIAM H QUIRK
Regulation Number880.5550
Classification Product Code
FNM  
Date Received08/22/1994
Decision Date 05/23/1995
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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