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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 K981112
Device Name MOBETRON
Applicant
INTRAOP MEDICAL, INC.
3170 DE LA CRUZ BLVD., #108
SANTA CLARA,  CA  95054
Applicant Contact DONALD A GOER
Correspondent
INTRAOP MEDICAL, INC.
3170 DE LA CRUZ BLVD., #108
SANTA CLARA,  CA  95054
Correspondent Contact DONALD A GOER
Regulation Number892.5050
Classification Product Code
LHN  
Date Received03/26/1998
Decision Date 07/24/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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