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510(k) K860148

MAZZOCCO/FRENCHIK FOLDER by Staar Surgical Co. — Product Code KYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1986
Date Received
January 15, 1986
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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  • K001157 — MONARCH II IOL DELIVERY SYSTEM (June 27, 2000)
  • K983129 — DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1) (December 4, 1998)