TEAR VOLUME TESTS

Strip, Schirmer

VISIONEX, INC.

The following data is part of a premarket notification filed by Visionex, Inc. with the FDA for Tear Volume Tests.

Pre-market Notification Details

Device IDK881515
510k NumberK881515
Device Name:TEAR VOLUME TESTS
ClassificationStrip, Schirmer
Applicant VISIONEX, INC. 1206 SARGENT DR. Sunnyvale,  CA  94087
ContactJessica Ayres
CorrespondentJessica Ayres
VISIONEX, INC. 1206 SARGENT DR. Sunnyvale,  CA  94087
Product CodeKYD  
CFR Regulation Number886.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-04-11
Decision Date1988-05-23

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