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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name accelerator, linear, medical
510(k) Number K991133
Device Name MLC FIT
Applicant
IMPAC MEDICAL SYSTEMS, INC.
215 CASTRO ST.
MOUNTAIN VIEW,  CA  94041 -1203
Applicant Contact THOMAS FARIS
Correspondent
IMPAC MEDICAL SYSTEMS, INC.
215 CASTRO ST.
MOUNTAIN VIEW,  CA  94041 -1203
Correspondent Contact THOMAS FARIS
Regulation Number892.5050
Classification Product Code
IYE  
Date Received04/02/1999
Decision Date 03/27/2000
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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