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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 K152321
Device Name kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracranial Fibreplast Variable Perf Head Only Open View w
Applicant
QFIX
440 CHURCH ROAD
AVONDALE,  PA  19311
Applicant Contact NADIA SOOKDEO HARHEN
Correspondent
QFIX
440 CHURCH ROAD
AVONDALE,  PA  19311
Correspondent Contact NADIA SOOKDEO HARHEN
Regulation Number892.5050
Classification Product Code
IYE  
Date Received08/17/2015
Decision Date 12/04/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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