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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name interventional fluoroscopic x-ray system
510(k) Number K092438
Device Name ZIEHM SOLO
Original Applicant
ZIEHM IMAGING, INC.
4181 latham st.
riverside,  CA  92501
Original Contact richard l westrich
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received08/07/2009
Decision Date 12/23/2009
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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