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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 K933402
Device Name TURBO II
Applicant
KINETIC CONCEPTS, INC.
4958 STOUT DR.
SAN ANTONIO,  TX  78219
Applicant Contact WILLIAM H QUIRK
Correspondent
KINETIC CONCEPTS, INC.
4958 STOUT DR.
SAN ANTONIO,  TX  78219
Correspondent Contact WILLIAM H QUIRK
Regulation Number880.5550
Classification Product Code
FNM  
Subsequent Product Code
IOQ  
Date Received07/12/1993
Decision Date 03/15/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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