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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 K955874
Device Name ALTACARE
Applicant
ASF INDUSTRIES, INC.
221 CENTER BAY DR.
WEST ISLIP,  NY  11795
Applicant Contact WILLIAM PELLEGRINO
Correspondent
ASF INDUSTRIES, INC.
221 CENTER BAY DR.
WEST ISLIP,  NY  11795
Correspondent Contact WILLIAM PELLEGRINO
Regulation Number880.5550
Classification Product Code
FNM  
Date Received12/28/1995
Decision Date 03/22/1996
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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