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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, fluoroscopic, image-intensified
510(k) Number K960266
Device Name SIREGRAPH CF
Original Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 wood avenue south
iselin,  NJ  08830
Original Contact kathy rutherford
Regulation Number892.1650
Classification Product Code
JAA  
Date Received01/18/1996
Decision Date 03/11/1996
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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