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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K992731
Device Name E.CAM COMPUTER
Applicant
Siemens Medical Solutions USA, Inc.
2501 N. Barrington Rd.
Hoffman Estates,  IL  60195 -7372
Applicant Contact ROBERT W CALLAHAN
Correspondent
Siemens Medical Solutions USA, Inc.
2501 N. Barrington Rd.
Hoffman Estates,  IL  60195 -7372
Correspondent Contact ROBERT W CALLAHAN
Regulation Number892.1200
Classification Product Code
KPS  
Date Received08/13/1999
Decision Date 11/10/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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