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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Couch, Radiation Therapy, Powered
510(k) Number K050422
Device Name 550 TXT TREATMENT TABLE
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 Number892.5770
Classification Product Code
JAI  
Date Received02/18/2005
Decision Date 03/18/2005
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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