PEDIATRIC VITRECTOMY LENS SET

Lens, Contact, Polymethylmethacrylate, Diagnostic

OCULAR INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Ocular Instruments, Inc. with the FDA for Pediatric Vitrectomy Lens Set.

Pre-market Notification Details

Device IDK914051
510k NumberK914051
Device Name:PEDIATRIC VITRECTOMY LENS SET
ClassificationLens, Contact, Polymethylmethacrylate, Diagnostic
Applicant OCULAR INSTRUMENTS, INC. 2255 116TH AVE., N.E. Bellevue,  WA  98004 -3039
ContactTamsin J Erickson
CorrespondentTamsin J Erickson
OCULAR INSTRUMENTS, INC. 2255 116TH AVE., N.E. Bellevue,  WA  98004 -3039
Product CodeHJK  
CFR Regulation Number886.1385 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-09-10
Decision Date1991-12-09

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