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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 K002237
Device Name P3IMRT TM
Applicant
ADAC LABORATORIES
540 ALDER DR.
MILPITAS,  CA  95035
Applicant Contact JANICE E BROWN
Correspondent
ADAC LABORATORIES
540 ALDER DR.
MILPITAS,  CA  95035
Correspondent Contact JANICE E BROWN
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received07/24/2000
Decision Date 02/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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