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510(k) K934337

CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE by Cuda Products Co. — Product Code FSW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 1993
Date Received
September 7, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Endoscopic
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances by Cuda Products Co.

  • K983277 — LIGHTSOURCE OR ILLUMINATOR MODEL I-100 (December 16, 1998)
  • 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 FSW

  • K022989 — RADLITE TISSUE RETRACTOR SYSTEM (November 25, 2002)
  • K013511 — XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~) (February 1, 2002)
  • K943342 — MEDICAM XENON LIGHT SOURCE (October 17, 1994)
  • K922279 — ILLUMINATOR IV MINOR SURGERY LIGHT (September 2, 1992)
  • K913135 — LM-300TWIN (September 18, 1991)
  • K894319 — MEDICAL DYNAMICS LIGHT SOURCE (October 3, 1989)
  • K870898 — ULTRA-LUX LIGHT SOURCE (March 18, 1987)