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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 K051932
Device Name ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5
Applicant
ELEKTA, INC
4775 PEACHTREE IND. BLVD
BUILDING 300, SUITE 300
NORCROSS,  GA  30092
Applicant Contact PETER STEGAGNO
Correspondent
ELEKTA, INC
4775 PEACHTREE IND. BLVD
BUILDING 300, SUITE 300
NORCROSS,  GA  30092
Correspondent Contact PETER STEGAGNO
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/13/2005
Decision Date 08/12/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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