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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K050297
Device Name SOMATOM EMOTION 16
Applicant
Siemens Medical Solution, Inc. USA
51 Valley Stream Pkwy. E50
Malvern,  PA  19355
Applicant Contact DEBRA PEACOCK
Correspondent
Siemens Medical Solution, Inc. USA
51 Valley Stream Pkwy. E50
Malvern,  PA  19355
Correspondent Contact DEBRA PEACOCK
Regulation Number892.1750
Classification Product Code
JAK  
Date Received02/07/2005
Decision Date 03/01/2005
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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