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510(k) K200874

TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End by Innovasis, Inc. — Product Code FST

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2020
Date Received
April 1, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Fiberoptic
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

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Other clearances for product code FST

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  • K100388 — 21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS (June 22, 2010)
  • K100395 — HARMONY VLED SURGICAL LIGHTNING SYSTEM (March 17, 2010)
  • K093386 — CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST (January 28, 2010)
  • K090070 — INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM (April 22, 2009)