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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 K981055
Device Name XKNIFE-4
Applicant
Radionics, Inc.
22 Terry Ave.
Burlington,  MA  01803 -2516
Applicant Contact LISA MISTERKA BENATI
Correspondent
Radionics, Inc.
22 Terry Ave.
Burlington,  MA  01803 -2516
Correspondent Contact LISA MISTERKA BENATI
Regulation Number892.5050
Classification Product Code
IYE  
Date Received03/23/1998
Decision Date 09/29/1998
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
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