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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 K990833
Device Name DOSE CALC, MODEL VS. 1.02
Applicant
Integrity Medical Software, Inc.
403 Mockingbird Ln.
Tyler,  TX  75701
Applicant Contact CRAIG A LAUGHTON
Correspondent
Integrity Medical Software, Inc.
403 Mockingbird Ln.
Tyler,  TX  75701
Correspondent Contact CRAIG A LAUGHTON
Regulation Number892.5050
Classification Product Code
IYE  
Date Received03/12/1999
Decision Date 06/08/1999
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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