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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Manual
510(k) Number K854257
Device Name COMBO 36
Applicant
Kg Engineering, Inc.
115 Front St.
Woonsocket,  RI  02895
Applicant Contact RALPH E LEADER
Correspondent
Kg Engineering, Inc.
115 Front St.
Woonsocket,  RI  02895
Correspondent Contact RALPH E LEADER
Regulation Number880.5120
Classification Product Code
FNJ  
Date Received10/22/1985
Decision Date 11/18/1985
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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