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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 K862065
Device Name PC-PLAN
Applicant
Dosimetrix, Inc.
714 Ninth St., Suite 207
Durham,  NC  27705
Applicant Contact NELSON, PHD
Correspondent
Dosimetrix, Inc.
714 Ninth St., Suite 207
Durham,  NC  27705
Correspondent Contact NELSON, PHD
Regulation Number892.5050
Classification Product Code
IYE  
Date Received05/30/1986
Decision Date 08/26/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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