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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 K925576
Device Name BURKE BARIATRIC TREATMENT SYSTEM II
Applicant
Burke Mobility Products
P.O. Box 1064
Mission,  KS  66222
Applicant Contact DUWAYNE E KRAMER
Correspondent
Burke Mobility Products
P.O. Box 1064
Mission,  KS  66222
Correspondent Contact DUWAYNE E KRAMER
Regulation Number880.5100
Classification Product Code
FNL  
Date Received11/03/1992
Decision Date 06/04/1993
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
Recalls CDRH Recalls
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