SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTOR

Folders And Injectors, Intraocular Lens (iol)

RAYNER INTRAOCULAR LENSES LTD.

The following data is part of a premarket notification filed by Rayner Intraocular Lenses Ltd. with the FDA for Single Use Soft Tipped Disposable Injector, Raysert Single Use Soft Tipped Small Incision Disposable Injector.

Pre-market Notification Details

Device IDK132002
510k NumberK132002
Device Name:SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTOR
ClassificationFolders And Injectors, Intraocular Lens (iol)
Applicant RAYNER INTRAOCULAR LENSES LTD. 1-2 SACKVILLE ROAD Hove, East Sussex,  GB Bn3 7an
ContactJuliette E Cook
Product CodeMSS  
CFR Regulation Number886.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2013-07-01
Decision Date2014-03-27
Summary:summary

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