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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 K962080
Device Name RPS-50 BEAM SCANNER
Applicant
Sofield Science Services, Inc.
243 Cherokee Trl.
Seymour,  TN  37865
Applicant Contact JACK C SOFIELD
Correspondent
Sofield Science Services, Inc.
243 Cherokee Trl.
Seymour,  TN  37865
Correspondent Contact JACK C SOFIELD
Regulation Number892.5050
Classification Product Code
IYE  
Date Received05/28/1996
Decision Date 08/23/1996
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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