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510(k) K781887

9100 DAYSTAR AND 9110 ORBITER PACKAGE by Castle Co. — Product Code FSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 1978
Date Received
November 7, 1978
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 Castle Co.

  • K870975 — MODIFIED CASTLE POWERCLAVE (April 17, 1987)
  • K860263 — CASTLE 7538 FLOOR LOADING WASHER (March 5, 1986)
  • K844089 — CASTLE 7515 UTENSIL/GLASSWARE WASHER (January 14, 1985)
  • K834048 — BOVIE CONDUCTIVE ADHES-DISPER-ELECTRO (April 4, 1984)
  • K833074 — CASTLE TEC-TEST S.M.A.R.T. PACK (November 7, 1983)
  • K831595 — CASTLE MODEL 3341 & 3441 & 4141 GAS AER (June 15, 1983)
  • K792660 — 1500 EO EXHAUST HOOD (January 29, 1980)
  • K792649 — UNISPORE-BIOLOGICAL INDICATORS (January 29, 1980)
  • K790677 — EO EVACUATING SYSTEM I (May 7, 1979)
  • K781484 — CASTLE MODEL 3146 GAS AERATOR (October 27, 1978)

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  • 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)