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510(k) K991208

ENDOSCOPIC FIBEROPTIC CABLE by Isolux America — Product Code HBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1999
Date Received
April 9, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Illuminator, Fiberoptic, Surgical Field
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances by Isolux America

  • K022384 — XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP (October 18, 2002)
  • K991572 — ISOLUX SURGICAL HEADLIGHT (July 8, 1999)

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  • K021931 — ENDOSCOPIC FIBEROPTIC CABLE (September 6, 2002)
  • K983277 — LIGHTSOURCE OR ILLUMINATOR MODEL I-100 (December 16, 1998)
  • K933593 — LUMINOUS 150 FIBEROPTIC ILLUMINATOR (October 28, 1993)
  • K922837 — S1500 XENON LIGHT SOURCE (November 3, 1992)
  • K922462 — NEXTEC FIBEROPTIC CABLES (September 21, 1992)