FDA 510(k) Application Details - K060903

Device Classification Name System, X-Ray, Tomography, Computed

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510(K) Number K060903
Device Name System, X-Ray, Tomography, Computed
Applicant VERAN MEDICAL TECHNOLOGIES, INC.
2409 21ST AVENUE SOUTH
SUITE 205
NASHVILLE, TN 37212 US
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Contact TORSTEN M LYON
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Regulation Number 892.1750

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Classification Product Code JAK
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Date Received 04/03/2006
Decision Date 05/11/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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