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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 K970819
Device Name TARGOBEAM
Applicant
Ferguson Medical
3407 Bay Ave.
Chico,  CA  95973
Applicant Contact FRANK FERGUSON
Correspondent
Ferguson Medical
3407 Bay Ave.
Chico,  CA  95973
Correspondent Contact FRANK FERGUSON
Regulation Number892.1750
Classification Product Code
JAK  
Date Received03/05/1997
Decision Date 07/14/1997
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
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