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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
Applicant
ZIEHM IMAGING, INC.
4181 LATHAM ST.
RIVERSIDE,  CA  92501
Applicant Contact RICHARD L WESTRICH
Correspondent
ZIEHM IMAGING, INC.
4181 LATHAM ST.
RIVERSIDE,  CA  92501
Correspondent 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 (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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