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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 K855063
Device Name UNIVERSAL PATIENT CHAIR UNI 2000X
Applicant
Siemens Medical Solutions USA, Inc.
186 Wood Ave. S.
Iselin,  NJ  08830
Applicant Contact HARRY K SCHWILL
Correspondent
Siemens Medical Solutions USA, Inc.
186 Wood Ave. S.
Iselin,  NJ  08830
Correspondent Contact HARRY K SCHWILL
Regulation Number892.5770
Classification Product Code
JAI  
Date Received12/18/1985
Decision Date 01/30/1986
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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