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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 K083545
Device Name ZIEHM VISION RFD
Applicant
Ziehm Imaging, Inc.
4181 Latham St.
Riverside,  CA  92501
Applicant Contact RICHARD WESTRICH
Correspondent
Ziehm Imaging, Inc.
4181 Latham St.
Riverside,  CA  92501
Correspondent Contact RICHARD WESTRICH
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received11/28/2008
Decision Date 05/15/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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