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510(k) K935818

ENDOSCOPE by Cuda Products Co. — Product Code GDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1994
Date Received
December 2, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope, Fiber Optic
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

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  • 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)
  • K933369 — CUDA PRODUCTS CORP. LIGHTSOURCES (January 3, 1994)
  • K934337 — CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE (November 18, 1993)

Other clearances for product code GDB

  • K032283 — DESIGNS FOR VISION FIBEROPTIC LIGHT (August 20, 2003)
  • K961536 — FLEXSCOPE (September 18, 1996)
  • K882061 — OLYMPUS GF-UM3/EU-M3 (November 15, 1988)
  • K855151 — FRITCH OPHTHALMIC ENDOSCOPE (February 19, 1986)
  • K843900 — FOCUSCOPE UNIVERSAL SYSTEM (December 6, 1984)
  • K810007 — PENTAX UPPER G.I. FIBERSCOPE, #FG-34 (January 15, 1981)