RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06

Folders And Injectors, Intraocular Lens (iol)

RAYNER SURGICAL INC

The following data is part of a premarket notification filed by Rayner Surgical Inc with the FDA for Rayner Single Use Small Incision Disposable Injector, Model R-inj-06.

Pre-market Notification Details

Device IDK081455
510k NumberK081455
Device Name:RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06
ClassificationFolders And Injectors, Intraocular Lens (iol)
Applicant RAYNER SURGICAL INC SACKVILLE ROAD Hove, East Sussex,  GB Bn3 7an
ContactAndrew Wells
CorrespondentAndrew Wells
RAYNER SURGICAL INC SACKVILLE ROAD Hove, East Sussex,  GB Bn3 7an
Product CodeMSS  
CFR Regulation Number886.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-05-23
Decision Date2008-09-05
Summary:summary

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