QUADRASPHERIC FUNDUS LENS

Lens, Contact, Polymethylmethacrylate, Diagnostic

VOLK OPTICAL, INC.

The following data is part of a premarket notification filed by Volk Optical, Inc. with the FDA for Quadraspheric Fundus Lens.

Pre-market Notification Details

Device IDK943125
510k NumberK943125
Device Name:QUADRASPHERIC FUNDUS LENS
ClassificationLens, Contact, Polymethylmethacrylate, Diagnostic
Applicant VOLK OPTICAL, INC. BOND COURT BUILDING 1300 EAST NINTH ST., STE 900 Cleveland,  OH  44114
ContactJames A Goldsmith
CorrespondentJames A Goldsmith
VOLK OPTICAL, INC. BOND COURT BUILDING 1300 EAST NINTH ST., STE 900 Cleveland,  OH  44114
Product CodeHJK  
CFR Regulation Number886.1385 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-06-29
Decision Date1994-09-02

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