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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 K992689
Device Name MU PLUS
Applicant
Rad Therapy Solutions, Inc.
738 Alden Dr.
Ormond Beach,  FL  32176
Applicant Contact STEVE GRUSE
Correspondent
Rad Therapy Solutions, Inc.
738 Alden Dr.
Ormond Beach,  FL  32176
Correspondent Contact STEVE GRUSE
Regulation Number892.5050
Classification Product Code
IYE  
Date Received08/10/1999
Decision Date 02/10/2000
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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