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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 K032209
Device Name NOMOS CORVUS 5.0M
Applicant
Nomos Corp.
200 W. Kensinger Dr.
Suite 100
Cranberry Township,  PA  16066
Applicant Contact FRANCIS X DOBSCHA
Correspondent
Nomos Corp.
200 W. Kensinger Dr.
Suite 100
Cranberry Township,  PA  16066
Correspondent Contact FRANCIS X DOBSCHA
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received07/18/2003
Decision Date 08/21/2003
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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