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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 K915061
Device Name PROACT CLA-1500 SYSTEM
Applicant
Clinical Systems, Inc.
10 Centre Dr.
Orchard Park,  NY  14127
Applicant Contact PETER SCOTT
Correspondent
Clinical Systems, Inc.
10 Centre Dr.
Orchard Park,  NY  14127
Correspondent Contact PETER SCOTT
Regulation Number880.5550
Classification Product Code
FNM  
Date Received11/08/1991
Decision Date 01/31/1992
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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