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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 K882161
Device Name ACUCAIR CUSHION CONTINUOUS AIRFLOW SYSTEM
Applicant
Ssi Medical Services, Inc.
Burditt Radzius Chartered
333 W.Wacker Dr.Suite 2600
Chicago,  IL  60606
Applicant Contact JOSEPH R RADZIUS
Correspondent
Ssi Medical Services, Inc.
Burditt Radzius Chartered
333 W.Wacker Dr.Suite 2600
Chicago,  IL  60606
Correspondent Contact JOSEPH R RADZIUS
Regulation Number880.5550
Classification Product Code
FNM  
Date Received05/23/1988
Decision Date 07/12/1988
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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