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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shield, Protective, Personnel
510(k) Number K951003
Device Name KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5)
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 Number892.6500
Classification Product Code
KPY  
Date Received02/15/1995
Decision Date 04/03/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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