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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screen, Leaded, Operator Radiation Protector
510(k) Number K944445
Device Name ED CORP RADIATION SCREEN
Applicant
Med Corp.
101 N. Dayon
P.O. Box 50010
Ames,  IA  50010
Applicant Contact WILLIAM R TOUT
Correspondent
Med Corp.
101 N. Dayon
P.O. Box 50010
Ames,  IA  50010
Correspondent Contact WILLIAM R TOUT
Regulation Number892.6500
Classification Product Code
EAK  
Date Received09/12/1994
Decision Date 05/11/1995
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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