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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 K013875
Device Name MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE
Applicant
MED-TEC,INC.
1401 8TH ST. S.E.
P.O. BOX 320
ORANGE CITY,  IA  51041
Applicant Contact DONALD F RIIBE
Correspondent
MED-TEC,INC.
1401 8TH ST. S.E.
P.O. BOX 320
ORANGE CITY,  IA  51041
Correspondent Contact DONALD F RIIBE
Regulation Number892.5710
Classification Product Code
IXI  
Date Received11/23/2001
Decision Date 09/27/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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