BAILEY LENS SHOOTER

Lens, Guide, Intraocular

INTERMEDICS INTRAOCULAR, INC.

The following data is part of a premarket notification filed by Intermedics Intraocular, Inc. with the FDA for Bailey Lens Shooter.

Pre-market Notification Details

Device IDK841730
510k NumberK841730
Device Name:BAILEY LENS SHOOTER
ClassificationLens, Guide, Intraocular
Applicant INTERMEDICS INTRAOCULAR, INC. P.O. BOX 617 Freeport,  TX  77541
ContactGrace Drucker
CorrespondentGrace Drucker
INTERMEDICS INTRAOCULAR, INC. P.O. BOX 617 Freeport,  TX  77541
Product CodeKYB  
CFR Regulation Number886.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-04-25
Decision Date1984-11-19

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