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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 K032456
Device Name PROWESS
Applicant
Prowess, Inc.
1370 Ridgewood Dr., #20
Chico,  CA  95973 -7803
Applicant Contact W. JAMES BISHOP
Correspondent
Prowess, Inc.
1370 Ridgewood Dr., #20
Chico,  CA  95973 -7803
Correspondent Contact W. JAMES BISHOP
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received08/11/2003
Decision Date 10/16/2003
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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