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510(k) K983129

DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1) by Staar Surgical Co. — Product Code KYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1998
Date Received
September 8, 1998
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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  • K954600 — MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION) (December 21, 1995)
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  • 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)
  • K981571 — MONARCH IOL DELIVERY SYSTEM (July 9, 1998)