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510(k) K935102

SATURN LIGHT by Burton Medical Products Corp. — Product Code FTA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1994
Date Received
October 22, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K963682 — GENIE' SINGLE CEILING AND DOUBLE CEILING (November 13, 1996)
  • K961843 — GENIE (August 22, 1996)
  • K942553 — GENESIS (June 23, 1994)
  • K936088 — WAVE FLUORESCENT MAGNIFIER (April 26, 1994)
  • K931645 — HALUX TASKLIGHT (August 20, 1993)
  • K901706 — LIGHT, HEAD, EXAMINATION (July 19, 1990)
  • K893807 — MODEL 0183010, PEARL MEDICAL EXAM LIGHT (August 15, 1989)

Other clearances for product code FTA

  • K150532 — Universal Light Handle Cover, Light Handle Cover (September 22, 2015)
  • K142386 — Operating Room Light Handle Adapter (September 29, 2014)
  • K133554 — SURGICAL LIGHT HANDLE COVER (April 8, 2014)
  • K133413 — IDSS SLC (January 7, 2014)
  • K112133 — OASYS SURGICAL LIGHT CONTROLLER (March 1, 2012)
  • K102791 — EASYSUITE SURGICAL LIGHT CONTROL (ESLC) (November 23, 2010)
  • K081698 — MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC) (July 30, 2008)
  • K053321 — LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER (January 19, 2006)
  • K051505 — SCB/STERIS OR-LIGHT INTERFACE BOX (August 11, 2005)
  • K023704 — KSEA SCB ACC CONTROL (January 30, 2003)