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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 K030175
Device Name 2 BASIC
Applicant
Capintec, Inc.
540 Alpha Dr.
Pittsburgh,  PA  15238
Applicant Contact MARY ANNE DELL
Correspondent
Capintec, Inc.
540 Alpha Dr.
Pittsburgh,  PA  15238
Correspondent Contact MARY ANNE DELL
Regulation Number892.5050
Classification Product Code
IYE  
Date Received01/17/2003
Decision Date 04/17/2003
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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