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510(k) K864801

THE KEYMED HI-LIGHT 250 LIGHT SOURCE by Keymed, Inc. — Product Code GCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 24, 1986
Date Received
December 9, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Source, Endoscope, Xenon Arc
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

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  • K861821 — KEYMED FIBERSCOPE AUTO DISINFECTOR (February 12, 1987)
  • K862000 — KEYMED FLEXIBLE ESOPHAGEAL DILATORS (August 12, 1986)
  • K860528 — THE KEYMED FIBERSCOPE STERILIZATION CASE (July 15, 1986)
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  • K860704 — THE KEYMED SIGMOIDOSCOPE DISINFECTION STAND (June 17, 1986)
  • K851149 — KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1 (November 26, 1985)
  • K854304 — KEYMED OFFICE COUCH (November 12, 1985)

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  • K020889 — ENDOSCOPIC LIGHT SOURCE XL202/L3 (June 5, 2002)
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