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510(k) K032412

RE-USEABLE MICROSTAAR INJECTOR, MSI-S by Staar Surgical Co. — Product Code KYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2004
Date Received
August 5, 2003
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

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Other clearances for product code KYB

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  • 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)
  • 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)