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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K150265
Device Name Model 206 Electrometer/Dosimeter
Applicant
Cnmc Company Incorporated
865 Easthagen Dr.
Nashville,  TN  37217
Applicant Contact THOMAS KRAUS
Correspondent
Cnmc Company Incorporated
865 Easthagen Dr.
Nashville,  TN  37217
Correspondent Contact THOMAS KRAUS
Regulation Number892.5050
Classification Product Code
IYE  
Date Received02/04/2015
Decision Date 09/03/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
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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