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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Ac-Powered Adjustable Hospital
510(k) Number K945042
Device Name ELITE 3 LOW AIR LOSS BED
Applicant
Pegabus Egerton, Ltd.
Farwig Ln., Bromley
Kent Br1 3tu,  GB
Applicant Contact M S THOMPSON
Correspondent
Pegabus Egerton, Ltd.
Farwig Ln., Bromley
Kent Br1 3tu,  GB
Correspondent Contact M S THOMPSON
Regulation Number880.5100
Classification Product Code
FNL  
Date Received10/14/1994
Decision Date 03/16/1995
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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