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510(k) K120796

SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER by Superdimension, Inc. — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2012
Date Received
March 15, 2012
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 Superdimension, Inc.

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  • K082386 — INREACH PLANNING LAPTOP (September 16, 2008)
  • K081379 — MODIFICATION TO INREACH SYSTEM (June 11, 2008)
  • K080271 — INREACH SYSTEM (March 31, 2008)
  • K071473 — MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2 (July 12, 2007)
  • K062315 — SUPERDIMENSION/BRONCHUS PREMIUM 2 (September 8, 2006)
  • K052852 — SUPERDIMENSION/BRONCHUS PREMIUM (November 14, 2005)
  • K052260 — SUPERDIMENSION/BRONCHUS 4.1 (September 8, 2005)

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