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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K132480
Device Name AIR-FLOW HANDY 3.0 PERIO
Applicant
E.M.S Electro Medical Systems S.A
62 Forest St., Suite 300
Marlborough,  MA  01752
Applicant Contact CYNTHIA J NOLTE
Correspondent
E.M.S Electro Medical Systems S.A
62 Forest St., Suite 300
Marlborough,  MA  01752
Correspondent Contact CYNTHIA J NOLTE
Regulation Number872.4200
Classification Product Code
EFB  
Date Received08/08/2013
Decision Date 02/24/2014
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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