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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 K032996
Device Name ELEKTA SYNERGY SYSTEM
Applicant
Elekta Oncology Systems, Ltd.
4775 Peachtree Industrial Blvd.
Bldg. 300, Suite 300
Norcross,  GA  30092
Applicant Contact PETER STEGAGNO
Correspondent
Elekta Oncology Systems, Ltd.
4775 Peachtree Industrial Blvd.
Bldg. 300, Suite 300
Norcross,  GA  30092
Correspondent Contact PETER STEGAGNO
Regulation Number892.5050
Classification Product Code
IYE  
Date Received09/25/2003
Decision Date 10/23/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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