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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 K972022
Device Name ZAK-2000
Applicant
Cardio Systems, Inc.
1201 N. Interstate 35
Carrollton,  TX  75006
Applicant Contact MIKE A SCANLAN
Correspondent
Cardio Systems, Inc.
1201 N. Interstate 35
Carrollton,  TX  75006
Correspondent Contact MIKE A SCANLAN
Regulation Number880.5550
Classification Product Code
FNM  
Date Received06/02/1997
Decision Date 01/22/1998
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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