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510(k) K851936

STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT by Staar Surgical Co. — Product Code HQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1985
Date Received
May 6, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Device Class
Class II
Regulation Number
886.4150
Review Panel
OP
Submission Type

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  • K073591 — MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM (March 13, 2008)
  • K073586 — MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM (March 13, 2008)
  • K032412 — RE-USEABLE MICROSTAAR INJECTOR, MSI-S (June 10, 2004)
  • K020734 — SURGE-FREE ASPIRATION ADAPTER (May 16, 2002)
  • K983129 — DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1) (December 4, 1998)
  • K980696 — FOAM TIP INJECTOR (September 11, 1998)
  • K954600 — MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION) (December 21, 1995)

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  • K033390 — COLIBRI DISPOSABLE VITRECTOMY CUTTER (November 4, 2003)
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