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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Block, Beam-Shaping, Radiation Therapy
510(k) Number K981992
Device Name ELECTRON WEDGE MODEL MT-EW-1000
Applicant
Med-Tec,Inc.
1401 8th St., SE
P.O. Box 320
Orange City,  IA  51041
Applicant Contact DONALD F RIIBE
Correspondent
Med-Tec,Inc.
1401 8th St., SE
P.O. Box 320
Orange City,  IA  51041
Correspondent Contact DONALD F RIIBE
Regulation Number892.5710
Classification Product Code
IXI  
Date Received06/08/1998
Decision Date 12/15/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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