DISPOSABLE MICROSTAAR INJECTOR

Lens, Guide, Intraocular

STAAR SUGICAL

The following data is part of a premarket notification filed by Staar Sugical with the FDA for Disposable Microstaar Injector.

Pre-market Notification Details

Device IDK940593
510k NumberK940593
Device Name:DISPOSABLE MICROSTAAR INJECTOR
ClassificationLens, Guide, Intraocular
Applicant STAAR SUGICAL 1911 WALKER AVE. Monrovia,  CA  91016
ContactSteven L Ziemba
CorrespondentSteven L Ziemba
STAAR SUGICAL 1911 WALKER AVE. Monrovia,  CA  91016
Product CodeKYB  
CFR Regulation Number886.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-02-09
Decision Date1994-09-19

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