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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 K072454
Device Name INTEGRA RADIONICS INTERFIX PATIENT ADAPTERS
Applicant
INTEGRA RADIONICS, INC.
22 TERRY AVENUE
BURLINGTON,  MA  01803
Applicant Contact KEVIN J O'CONNELL
Correspondent
INTEGRA RADIONICS, INC.
22 TERRY AVENUE
BURLINGTON,  MA  01803
Correspondent Contact KEVIN J O'CONNELL
Regulation Number892.5050
Classification Product Code
IYE  
Date Received08/31/2007
Decision Date 10/16/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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