OCULAR FORCE GAUGE

Tonometer, Manual

OCULAR THERAPEUTIX, INC.

The following data is part of a premarket notification filed by Ocular Therapeutix, Inc. with the FDA for Ocular Force Gauge.

Pre-market Notification Details

Device IDK132917
510k NumberK132917
Device Name:OCULAR FORCE GAUGE
ClassificationTonometer, Manual
Applicant OCULAR THERAPEUTIX, INC. 36 Crosby Dr Ste 101 Bedford,  MA  01730
ContactEric Ankerud
CorrespondentEric Ankerud
OCULAR THERAPEUTIX, INC. 36 Crosby Dr Ste 101 Bedford,  MA  01730
Product CodeHKY  
CFR Regulation Number886.1930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-09-17
Decision Date2013-12-20
Summary:summary

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