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510(k) K905282

ENDOSCOPIC ACCESSORY TO THE LIGHT SOURCE by Frantz Medical Development, Ltd. — Product Code GCT

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
March 19, 1991
Date Received
November 23, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Source, Endoscope, Xenon Arc
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Frantz Medical Development, Ltd.

  • K981541 — CLEARSTAR ENTERAL NUTRITION PUMP (August 13, 1998)
  • K873119 — FLEXIFLO COMPANION ENTERAL NUTRITION PUMP (November 5, 1987)
  • K871710 — BIOPSY FORCEPS (August 10, 1987)
  • K863508 — FRANTZ MEDICAL ELECTRODE (February 6, 1987)

Other clearances for product code GCT

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  • K082925 — XENON-100 SCB LIGHT SOURCE, MODEL 20132620 (December 18, 2008)
  • K070376 — CONMED LINVATEC 300W XENON LIGHT SOURCE (August 20, 2007)
  • K040949 — VIADUCT MINISCOPE AND ACCESSORIES (May 7, 2004)
  • K022490 — KSEA MEDI PACK (September 29, 2003)
  • K031994 — LINVATEC 300W XENON LIGHT SOURCE (August 21, 2003)
  • K023468 — ENDOSCOPIC LIGHT SOURCE XL180/L3 (January 14, 2003)
  • K021717 — ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5 (August 20, 2002)
  • K020889 — ENDOSCOPIC LIGHT SOURCE XL202/L3 (June 5, 2002)
  • K013880 — DAYLITE XENON LIGHT SOURCES (December 7, 2001)