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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 K771463
Device Name AERO PULSE ALTERNATING PRES. PUMP
Applicant
MEDLINE INDUSTRIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MEDLINE INDUSTRIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.5550
Classification Product Code
FNM  
Date Received08/04/1977
Decision Date 08/26/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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