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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Block, Beam-Shaping, Radiation Therapy
510(k) Number K032790
Device Name MICROMLC
Applicant
Siemens Medical Solutions USA, Inc.
4040 Nelson Ave.
Concord,  CA  94520
Applicant Contact KEN NEHMER
Correspondent
Siemens Medical Solutions USA, Inc.
4040 Nelson Ave.
Concord,  CA  94520
Correspondent Contact KEN NEHMER
Regulation Number892.5710
Classification Product Code
IXI  
Date Received09/08/2003
Decision Date 10/02/2003
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
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