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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 K080847
Device Name RFVISION, MODEL 9.9D
Applicant
ALMANA MEDICAL IMAGING
PO BOX 7007
DEERFIELD,  IL  60015
Applicant Contact DANIEL KAMM, P.E
Correspondent
ALMANA MEDICAL IMAGING
PO BOX 7007
DEERFIELD,  IL  60015
Correspondent Contact DANIEL KAMM, P.E
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received03/26/2008
Decision Date 08/06/2008
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
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