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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 K961159
Device Name POWERED LOW AIR LOSS MATTRESS SYSTEM
Applicant
Span-America Medical Systems, Inc.
P.O. Box 5231
Greenville,  SC  29606
Applicant Contact WANDA TOTTON
Correspondent
Span-America Medical Systems, Inc.
P.O. Box 5231
Greenville,  SC  29606
Correspondent Contact WANDA TOTTON
Regulation Number880.5550
Classification Product Code
FNM  
Date Received03/22/1996
Decision Date 06/14/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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