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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 K984196
Device Name MODIFICATION TO PROWESS PRO-SIM
Applicant
Ssgi Prowess Systems
1370 Ridgewood Dr., #20
Chico,  CA  95973 -7803
Applicant Contact ROBERT J MORTON
Correspondent
Ssgi Prowess Systems
1370 Ridgewood Dr., #20
Chico,  CA  95973 -7803
Correspondent Contact ROBERT J MORTON
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received11/23/1998
Decision Date 12/11/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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