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510(k) K032283

DESIGNS FOR VISION FIBEROPTIC LIGHT by Designs For Vision, Inc. — Product Code GDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2003
Date Received
July 24, 2003
Clearance Type
Special
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

Other clearances by Designs For Vision, Inc.

  • K051786 — MELIDE FIBEROPTIC LIGHT (August 15, 2005)
  • K043530 — DVI CURING LIGHT (January 25, 2005)
  • K013880 — DAYLITE XENON LIGHT SOURCES (December 7, 2001)
  • K801058 — ILLUMINATED SPECULUM (May 28, 1980)

Other clearances for product code GDB

  • K961536 — FLEXSCOPE (September 18, 1996)
  • K935818 — ENDOSCOPE (July 13, 1994)
  • 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)