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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 K082791
Device Name EMS AIR-FLOW MASTER
Applicant
E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
49 PLAIN ST
NORTH ATTLEBORO,  MA  02760
Applicant Contact CYNTHIA J NOLTE
Correspondent
E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
49 PLAIN ST
NORTH ATTLEBORO,  MA  02760
Correspondent Contact CYNTHIA J NOLTE
Regulation Number872.4200
Classification Product Code
EFB  
Date Received09/23/2008
Decision Date 02/18/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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