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510(k) K902784

FIBER OPTIC LIGHT SOURCE by Trek Medical Products, Inc. — Product Code EQH

K902784 is an FDA 510(k) premarket notification submitted by Trek Medical Products, Inc. for the device "FIBER OPTIC LIGHT SOURCE". The FDA issued a decision of Substantially Equivalent on September 12, 1990. The device falls under product code EQH (Source, Carrier, Fiberoptic Light), a Class I device regulated under 21 CFR 874.4350. Trek Medical Products, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1990
Date Received
June 26, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Carrier, Fiberoptic Light
Device Class
Class I
Regulation Number
874.4350
Review Panel
EN
Submission Type

Other clearances by Trek Medical Products, Inc.

  • K920937 — COMPUTERIZED PUPIL (October 2, 1992)
  • K920944 — FTS-200 GAS SYSTEM (May 29, 1992)
  • K900808 — RAPID AUTOMATIC PNEUMOPERITONEUM-I (September 19, 1990)
  • K895813 — GLAUCOMA MECHANICAL TREPHINE (April 30, 1990)
  • K882403 — OPHTHALMIC FLUID INJECTOR (September 9, 1988)
  • K875195 — OPHTHALMIC LIGHT PIPE PICK (March 7, 1988)
  • K864035 — VES-10 INTRAOCULAR SCISSORS DRIVE (December 15, 1986)

Other clearances for product code EQH

  • K945876 — WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT (December 4, 1995)
  • K954184 — JED-LIGHT FIBEROPTIC LIGHT SOURCE (November 13, 1995)
  • K951829 — COLD LIGHT SOURCE LOS 150 (July 10, 1995)
  • K932771 — BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE (August 24, 1994)
  • K941661 — GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT (August 23, 1994)
  • K941662 — GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT (July 20, 1994)
  • K934911 — SAPHIRE PLUS SURGICAL MIRROR (June 21, 1994)
  • K932131 — MID LABS TWIN ILLUMINATOR (April 1, 1994)
  • K930123 — ASPIRATING ENDO OCULAR PROBE (February 16, 1994)
  • K933145 — FIBEROPTIC LIGHTSOURCES AND CARRIERS (September 7, 1993)

FDA data resources