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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 K073284
Device Name AIR-FLOW MASTER STANDARD
Applicant
(EMS SA) ELECTRO MEDICAL SYSTEMS
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Applicant Contact SUSAN M BONAPACE
Correspondent
(EMS SA) ELECTRO MEDICAL SYSTEMS
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Correspondent Contact SUSAN M BONAPACE
Regulation Number872.4200
Classification Product Code
EFB  
Subsequent Product Code
KOJ  
Date Received11/21/2007
Decision Date 12/14/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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