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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 K152761
Device Name Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft Tissue (17G)
Applicant
VARIAN MEDICAL SYSTEMS, INC.
2101 4TH AVE, SUITE 100
SEATTLE,  WA  98121
Applicant Contact MARCIA PAGE
Correspondent
VARIAN MEDICAL SYSTEMS, INC.
2101 4TH AVE, SUITE 100
SEATTLE,  WA  98121
Correspondent Contact MARCIA PAGE
Regulation Number892.5050
Classification Product Code
IYE  
Date Received09/24/2015
Decision Date 11/25/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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