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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Brachytherapy, Radionuclide
510(k) Number K021360
Device Name SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000
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 Number892.5730
Classification Product Code
KXK  
Date Received04/30/2002
Decision Date 06/10/2003
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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