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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drill, Bone, Powered
510(k) Number K072146
Device Name EMS PIEZON MASTER SURGERY
Applicant
E.M.S Electro Medical Systems S.A
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact SUSAN BONAPACE
Correspondent
E.M.S Electro Medical Systems S.A
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact SUSAN BONAPACE
Regulation Number872.4120
Classification Product Code
DZI  
Date Received08/03/2007
Decision Date 12/18/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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