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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Radiation Therapy, Charged-Particle, Medical
510(k) Number K981115
Device Name RADIO-PLAST
Applicant
Smith & Nephew, Inc.
N104 W13400 Donges Bay Rd.
Germantown,  WI  53022
Applicant Contact CORDELL C HOFFINS
Correspondent
Smith & Nephew, Inc.
N104 W13400 Donges Bay Rd.
Germantown,  WI  53022
Correspondent Contact CORDELL C HOFFINS
Regulation Number892.5050
Classification Product Code
LHN  
Subsequent Product Code
IWB  
Date Received03/27/1998
Decision Date 06/25/1998
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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