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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 K891266
Device Name NEUROFOCAL COLLIMATOR
Applicant
Siemens Gammasonics, Inc.
2000 Nuclear Dr.
Des Plaines,  IL  60018
Applicant Contact W HENKELMAN
Correspondent
Siemens Gammasonics, Inc.
2000 Nuclear Dr.
Des Plaines,  IL  60018
Correspondent Contact W HENKELMAN
Regulation Number892.1200
Classification Product Code
KPS  
Date Received03/08/1989
Decision Date 04/17/1989
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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