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510(k) K081382

DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786 by Duckworth & Kent, Ltd. — Product Code KYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2008
Date Received
May 16, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Guide, Intraocular
Device Class
Class I
Regulation Number
886.4300
Review Panel
OP
Submission Type

Other clearances by Duckworth & Kent, Ltd.

  • K072985 — DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2 (June 20, 2008)
  • K060995 — DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM, MODEL DK7788 (May 22, 2006)
  • K053176 — DUCKWORTH & KENT LTD CARTRIDGE LENS DELIVERY SYSTEM, MODEL DK7797 (January 30, 2006)
  • K042478 — CAPSULE TENSION RING INSERTER, MODEL 7-810 (December 28, 2004)
  • K024072 — DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM (October 6, 2003)

Other clearances for product code KYB

  • K152357 — MicroSTAAR Injector System Cartridges (October 30, 2015)
  • K072985 — DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2 (June 20, 2008)
  • K070669 — IOL INJECTOR SET (November 1, 2007)
  • K063155 — MONARCH III IOL DELIVERY SYSTEM (March 27, 2007)
  • K063694 — AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28 (March 7, 2007)
  • K032412 — RE-USEABLE MICROSTAAR INJECTOR, MSI-S (June 10, 2004)
  • K022723 — MASTEL 1 FOLDER IMPLANTATION SYSTEM (December 26, 2002)
  • K001157 — MONARCH II IOL DELIVERY SYSTEM (June 27, 2000)
  • K983129 — DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1) (December 4, 1998)
  • K981571 — MONARCH IOL DELIVERY SYSTEM (July 9, 1998)