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510(k) K893458

FIBEROPTIC HEADLIGHT SYSTEM by Cuda Products Co. — Product Code EBA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1989
Date Received
May 2, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical Headlight
Device Class
Class I
Regulation Number
872.4630
Review Panel
DE
Submission Type

Other clearances by Cuda Products Co.

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  • K981962 — CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE (August 18, 1998)
  • K981469 — CERMAX300 LIGHTSOURCE (July 9, 1998)
  • K980350 — VIDEO CAMERA/LIGHTSOURCE COMBINATION UNIT MODEL VCL-150 (April 28, 1998)
  • K980166 — LIGHTSOURCE OR ILLUMINATOR (April 1, 1998)
  • K961074 — LIGHTSOURCE OR ILLUMINATOR (April 30, 1996)
  • K951019 — INTRAORAL VIDEO SCOPE AND WINDOW TUBE (May 10, 1995)
  • K943731 — VIDEO OTOSCOPE (October 11, 1994)
  • K935818 — ENDOSCOPE (July 13, 1994)
  • K933369 — CUDA PRODUCTS CORP. LIGHTSOURCES (January 3, 1994)

Other clearances for product code EBA

  • K070287 — PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500 (February 12, 2007)
  • K923949 — SYLVAN DENTAL HEADLIGHT SYSTEM (October 16, 1992)
  • K854646 — VEGA DENTAL OPERATING LIGHT (March 6, 1986)
  • K842515 — SURGICAL HEADLIGHT (August 2, 1984)
  • K842358 — ISOLIGHT (July 31, 1984)
  • K822265 — FIBEROPTIC LIGHT SOURCE W/RELATED ITEMS (September 28, 1982)
  • K810117 — HALOGEN HEADLIGHT SYSTEM (February 10, 1981)
  • K790807 — METALIT (August 3, 1979)
  • K790806 — PORCELIT (August 3, 1979)