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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lift, Patient, Ac-Powered
510(k) Number K862147
Device Name BOMDAL STANDARD LIFT
Applicant
Bomdal Medical Equipment, Inc.
51 Valecrest Dr.
Islington, Ontario,  CA M9A 4P5
Applicant Contact ANGELO BONETTA
Correspondent
Bomdal Medical Equipment, Inc.
51 Valecrest Dr.
Islington, Ontario,  CA M9A 4P5
Correspondent Contact ANGELO BONETTA
Regulation Number880.5500
Classification Product Code
FNG  
Date Received06/04/1986
Decision Date 07/15/1986
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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