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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K023293
Device Name MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02
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 Number892.5050
Classification Product Code
IYE  
Date Received10/02/2002
Decision Date 12/23/2002
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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