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510(k) K142076

CLAVEGUARD FREEDOM SURGICAL LIGHT by Dickson & Dickson Healthcare (Us), Inc. — Product Code FSY

K142076 is an FDA 510(k) premarket notification submitted by Dickson & Dickson Healthcare (Us), Inc. for the device "CLAVEGUARD FREEDOM SURGICAL LIGHT". The FDA issued a decision of Substantially Equivalent on September 30, 2014. The device falls under product code FSY (Light, Surgical, Ceiling Mounted), a Class II device regulated under 21 CFR 878.4580.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2014
Date Received
July 31, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances for product code FSY

  • K142984 — Leo Minor (October 29, 2014)
  • K140812 — MI-750 PROCEDURAL/MINOR SURGICAL LIGHT (August 7, 2014)
  • K132551 — ZF 720 (June 30, 2014)
  • K140930 — VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES (June 9, 2014)
  • K140461 — MACH LED 2MC (April 3, 2014)
  • K140460 — MACH LED 2SC (April 3, 2014)
  • K132747 — VISUM BLADE LED SURGICAL LIGHTING SYSTEM (December 30, 2013)
  • K132307 — VIDA LED SURGICAL LIGHTING SYSTEM (November 5, 2013)
  • K131893 — AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS (October 30, 2013)
  • K122875 — ORICARE L2700 (December 18, 2012)

FDA data resources