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510(k) K962606

TOPOGRAPHIC IMAGING MARKER by I.Z.I. Medical Products Corp. — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1996
Date Received
July 2, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Other clearances by I.Z.I. Medical Products Corp.

  • K990242 — TOPOGRAPHIC IMAGING MARKER (March 3, 1999)
  • K990298 — TOPOGRAPHIC IMAGING MARKER (March 3, 1999)
  • K964972 — SHADOWFORM (May 5, 1997)

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