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510(k) K133425

SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT by Engineered Medical Solutions Co., LLC — Product Code FTD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2013
Date Received
November 8, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Engineered Medical Solutions Co., LLC

  • K071180 — SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 (June 20, 2007)

Other clearances for product code FTD

  • K130513 — VOLISTA 400; VOLISTA 600 (May 8, 2013)
  • K123776 — POLARIS 100/200 (March 8, 2013)
  • K111020 — ATRICURE DISSECTOR (June 9, 2011)
  • K100234 — HM-LAMP II (July 8, 2010)
  • K100884 — STRYKER KNIFELIGHT (June 25, 2010)
  • K071180 — SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 (June 20, 2007)
  • K053364 — HALUX IRIS EXAMINATION AND SURGICAL LAMP (February 23, 2006)
  • K041681 — ATRICURE DISSECTOR (July 1, 2004)
  • K013242 — AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM (December 13, 2001)
  • K010724 — SOLA 700,SOLA 500, SOLA 300 (June 7, 2001)