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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 K993425
Device Name PRIMUS
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
4040 NELSON AVE.
CONCORD,  CA  94520
Applicant Contact KATHRYN B DODD
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
4040 NELSON AVE.
CONCORD,  CA  94520
Correspondent Contact KATHRYN B DODD
Regulation Number892.5050
Classification Product Code
IYE  
Date Received10/12/1999
Decision Date 11/26/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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