HOYA IS INJECTOR SYSTEM

Folders And Injectors, Intraocular Lens (iol)

HOYA SURGICAL OPTICS, INC.

The following data is part of a premarket notification filed by Hoya Surgical Optics, Inc. with the FDA for Hoya Is Injector System.

Pre-market Notification Details

Device IDK081346
510k NumberK081346
Device Name:HOYA IS INJECTOR SYSTEM
ClassificationFolders And Injectors, Intraocular Lens (iol)
Applicant HOYA SURGICAL OPTICS, INC. 14768 PIPELINE AVE. Chino Hills,  CA  91709
ContactSteven L Ziemba
CorrespondentSteven L Ziemba
HOYA SURGICAL OPTICS, INC. 14768 PIPELINE AVE. Chino Hills,  CA  91709
Product CodeMSS  
CFR Regulation Number886.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-05-14
Decision Date2009-03-23

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