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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 K970081
Device Name SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM
Applicant
Cathay Consolidated, Inc.
P.O. Box 333
Taipei,  TW
Applicant Contact JEAN ROZINT
Correspondent
Cathay Consolidated, Inc.
P.O. Box 333
Taipei,  TW
Correspondent Contact JEAN ROZINT
Regulation Number880.5550
Classification Product Code
FNM  
Date Received01/09/1997
Decision Date 11/07/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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