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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, planning, radiation therapy treatment
510(k) Number K100417
Device Name XKNIFE 5
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
MUJ  
Date Received02/16/2010
Decision Date 04/08/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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