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510(k) K050638

LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES by Lenstec, Inc. — Product Code MSS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 2005
Date Received
March 11, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Folders And Injectors, Intraocular Lens (Iol)
Device Class
Class I
Regulation Number
886.4300
Review Panel
OP
Submission Type

Other clearances by Lenstec, Inc.

  • K161776 — Lenstec LC Injection system (November 29, 2016)
  • K122848 — LENSTEC LC INJECTION SYSTEM (October 18, 2013)
  • K091915 — FLUID ISOLATION DEVICE (October 27, 2009)
  • K063802 — LENSTEC LC INJECTION SYSTEM (May 7, 2007)
  • K060533 — LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM (April 14, 2006)

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