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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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