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510(k) K954842

D.O.R.C. VFI/VFE SYSTEM by Dutch Ophthalmic USA, Inc. — Product Code KYG

K954842 is an FDA 510(k) premarket notification submitted by Dutch Ophthalmic USA, Inc. for the device "D.O.R.C. VFI/VFE SYSTEM". The FDA issued a decision of Substantially Equivalent on April 15, 1996. The device falls under product code KYG (Device, Irrigation, Ocular Surgery), a Class I device regulated under 21 CFR 886.4360. Dutch Ophthalmic USA, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1996
Date Received
October 23, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Irrigation, Ocular Surgery
Device Class
Class I
Regulation Number
886.4360
Review Panel
OP
Submission Type

Other clearances by Dutch Ophthalmic USA, Inc.

  • K012821 — D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM (October 22, 2001)
  • K010082 — D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM (March 12, 2001)
  • K983797 — D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM (March 3, 1999)
  • K980636 — FIBER OPTIC ENDOILLUMINATION PROBE (May 20, 1998)
  • K973229 — D.O.R.C. HEXON ILLUMINATION SYSTEM (November 25, 1997)
  • K973757 — D.O.R.C. SOLUX LIGHT SOURCE (November 7, 1997)
  • K962135 — D.O.R.C. MICRODIATHERMY SYSTEM (August 29, 1996)
  • K940373 — OPHTHALMIC CRYO UNIT (July 18, 1994)
  • K902491 — ECKHARDT TEMPORARY KERATOPROSTHESIS (June 26, 1990)

Other clearances for product code KYG

  • K010353 — MED-LOGICS DISPOSABLE ALK TUBING (April 27, 2001)
  • K003036 — TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,10102 (December 22, 2000)
  • K993591 — BLADEWORKS DISPOSABLE ALK TUBING (December 28, 1999)
  • K981116 — SOVEREIGN CATARACT EXTRACTION SYSTEM (May 19, 1998)
  • K980647 — EYE IRRIGATOR MODEL #2020 (May 15, 1998)
  • K974561 — MOISTAIR FLUID AIR TUBING SET (February 19, 1998)
  • K971173 — ML DISPOSABLE ALK TUBING (May 22, 1997)
  • K970161 — HEDGES CORNEAL WETTING PAK (March 25, 1997)
  • K945171 — DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE (February 8, 1995)
  • K940392 — PEREGRINE PIC MINIPULATOR (August 23, 1994)

FDA data resources