FDA 510(k) Application Details - K960146

Device Classification Name System, X-Ray, Photofluorographic

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510(K) Number K960146
Device Name System, X-Ray, Photofluorographic
Applicant GE MEDICAL SYSTEMS
1247 FLORDIA AVE.
PALM HARBOR, FL 34683 US
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Contact PATRICK J LAMB
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Regulation Number 892.1730

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Classification Product Code IZG
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Date Received 01/16/1996
Decision Date 02/27/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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