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510(k) K141091

RAYSERT PLUS INJECTOR by Rayner Intraocular Lenses , Ltd. — Product Code MSS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2014
Date Received
April 28, 2014
Clearance Type
Special
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 Rayner Intraocular Lenses , Ltd.

  • K143307 — RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector (December 18, 2014)
  • K132002 — SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL (March 27, 2014)
  • K091507 — RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18 (December 4, 2009)

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