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510(k) K201898

Clear Guide SCENERGY by Clear Guide Medical — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2020
Date Received
July 2, 2020
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 Clear Guide Medical

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  • K201188 — Clear Guide SCENERGY (September 30, 2020)
  • K171677 — Clear Guide SCENERGY (December 8, 2017)
  • K153004 — Clear Guide SCENERGY (February 12, 2016)
  • K141806 — CLEAR GUIDE ONE (September 19, 2014)

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