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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Couch, Radiation Therapy, Powered
510(k) Number K983678
Device Name ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE
Applicant
Elekta Instruments, Inc.
3155 Northwoods Pkwy. NW
Norcross,  GA  30071
Applicant Contact PAUL L SUMNER
Correspondent
Elekta Instruments, Inc.
3155 Northwoods Pkwy. NW
Norcross,  GA  30071
Correspondent Contact PAUL L SUMNER
Regulation Number892.5770
Classification Product Code
JAI  
Date Received10/20/1998
Decision Date 01/15/1999
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
Recalls CDRH Recalls
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