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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 K910971
Device Name Z XT RADIATION THERAPY TREATMENT TABLE
Applicant
Siemens Medical Laboratories, Inc.
4040 Nelson Ave.
Concord,  CA  94520
Applicant Contact MORTON, JR
Correspondent
Siemens Medical Laboratories, Inc.
4040 Nelson Ave.
Concord,  CA  94520
Correspondent Contact MORTON, JR
Regulation Number892.5770
Classification Product Code
JAI  
Date Received03/07/1991
Decision Date 05/03/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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