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510(k) K854922

AMSCO POLARIS SL by Amsco Co. — Product Code FSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1986
Date Received
December 10, 1985
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 by Amsco Co.

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  • K833187 — HALL OSTEON (October 31, 1983)
  • K832945 — EAGLE 2000 STERILIZER SERIES GAS/AERA (October 19, 1983)
  • K832186 — HALL DRILL/REAMER (August 12, 1983)
  • K832188 — HALL RECIPROCATOR (August 12, 1983)
  • K831086 — CEILING MOUNTED SUPPORT (August 12, 1983)
  • K832187 — HALL OSCILLATOR (August 12, 1983)
  • K831309 — DELIVERY 4 TABLE (June 15, 1983)
  • K823360 — SURGICAL LIGHT (December 3, 1982)
  • K811242 — DISPOSABLE STERILIZATION WRAP (May 21, 1981)

Other clearances for product code FSY

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  • 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)