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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 K951112
Device Name PRESSUREGUARD IV
Applicant
Span-America Medical Systems, Inc.
P.O. Box 5231
Greenville,  SC  29606
Applicant Contact CHARLES B MITCHELL
Correspondent
Span-America Medical Systems, Inc.
P.O. Box 5231
Greenville,  SC  29606
Correspondent Contact CHARLES B MITCHELL
Regulation Number880.5550
Classification Product Code
FNM  
Date Received03/10/1995
Decision Date 06/06/1995
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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