BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY

Lens, Contact (other Material) - Daily

POLYMER TECHNOLOGY

The following data is part of a premarket notification filed by Polymer Technology with the FDA for Boston Eo (enflufocon B) Contact Lens For Orthokeratolgy.

Pre-market Notification Details

Device IDK003932
510k NumberK003932
Device Name:BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY
ClassificationLens, Contact (other Material) - Daily
Applicant POLYMER TECHNOLOGY 1400 N GOODMAN ST. Rochester,  NY  14603 -0450
ContactNancy Abraham
CorrespondentNancy Abraham
POLYMER TECHNOLOGY 1400 N GOODMAN ST. Rochester,  NY  14603 -0450
Product CodeHQD  
CFR Regulation Number886.5916 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-12-20
Decision Date2001-02-16

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