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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 K062817
Device Name PTW DAVID IMRT QC VERIFICATION SYSTEM
Applicant
Ptw-New York Corp.
205 Park Ave.
Hicksville,  NY  11801
Applicant Contact RICHARD D BARKER
Correspondent
Ptw-New York Corp.
205 Park Ave.
Hicksville,  NY  11801
Correspondent Contact RICHARD D BARKER
Regulation Number892.5050
Classification Product Code
IYE  
Date Received09/20/2006
Decision Date 11/22/2006
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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