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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Stationary
510(k) Number K011111
Device Name MXD100/MX 20, OR MX 30, OR MX 40 OR MX 50--(MXD 100 SERIES)
Applicant
Modular X-Ray Devices
P.O. Box 2878
Honeydew 2040
Roodepoort,  ZA 2040
Applicant Contact S.B.B. DESEMBERG
Correspondent
Modular X-Ray Devices
P.O. Box 2878
Honeydew 2040
Roodepoort,  ZA 2040
Correspondent Contact S.B.B. DESEMBERG
Regulation Number892.1680
Classification Product Code
KPR  
Date Received04/11/2001
Decision Date 05/30/2001
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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