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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Simulation, Radiation Therapy
510(k) Number K894568
Device Name NEW RAD-8 TREATMENT PLANNING COMPUTER SYSTEM
Applicant
Advanced Medical Systems, Inc.
121 N. Eagle St.
Geneva,  OH  44041
Applicant Contact SHERRY STEIN
Correspondent
Advanced Medical Systems, Inc.
121 N. Eagle St.
Geneva,  OH  44041
Correspondent Contact SHERRY STEIN
Regulation Number892.5840
Classification Product Code
KPQ  
Date Received07/21/1989
Decision Date 01/09/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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