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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 K981313
Device Name SEQUENCER
Applicant
IMPAC MEDICAL SYSTEMS, INC.
215 CASTRO ST.
MOUNTAIN VIEW,  CA  94041 -1203
Applicant Contact JAMES HOEY
Correspondent
IMPAC MEDICAL SYSTEMS, INC.
215 CASTRO ST.
MOUNTAIN VIEW,  CA  94041 -1203
Correspondent Contact JAMES HOEY
Regulation Number892.5050
Classification Product Code
IYE  
Date Received04/10/1998
Decision Date 07/09/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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