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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Extraoral With Timer
510(k) Number K965203
Device Name RADX SYSTEM
Applicant
Electro Medical Systems, Inc.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact STEVEN A CLARKE
Correspondent
Electro Medical Systems, Inc.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact STEVEN A CLARKE
Regulation Number872.1800
Classification Product Code
EHD  
Date Received12/26/1996
Decision Date 03/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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