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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector, Contrast Medium, Automatic
510(k) Number K951005
Device Name KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2)
Applicant
Kenex , Ltd.
Langley House 24 Burnt Mill
Harlow Essex Cm20 2hs
England,  GB
Applicant Contact K. C. HUNT
Correspondent
Kenex , Ltd.
Langley House 24 Burnt Mill
Harlow Essex Cm20 2hs
England,  GB
Correspondent Contact K. C. HUNT
Regulation Number870.1650
Classification Product Code
IZQ  
Date Received02/15/1995
Decision Date 05/04/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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