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510(k) K003736

MRI LINE MARKER by I.Z.I. Corp. — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2001
Date Received
December 4, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

Other clearances by I.Z.I. Corp.

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  • K930752 — CT/MRI TOPOGRAPHIC MARKER (November 19, 1993)
  • K922287 — E.Z. PORT(TM) RADIATION THERAPY SKIN MARKERS (October 16, 1992)

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