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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 K945041
Device Name PARAGON PORTABLE
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 Number880.5550
Classification Product Code
FNM  
Subsequent Product Codes
INM   IOQ  
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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