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510(k) K021360

SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000 by Med-Tec,Inc. — Product Code KXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2003
Date Received
April 30, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Brachytherapy, Radionuclide
Device Class
Class II
Regulation Number
892.5730
Review Panel
RA
Submission Type

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  • K023293 — MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02 (December 23, 2002)
  • K013875 — MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE (September 27, 2002)
  • K001052 — MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX (August 30, 2000)
  • K981992 — ELECTRON WEDGE MODEL MT-EW-1000 (December 15, 1998)
  • K982624 — MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242 (October 26, 1998)

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