SCLERAL PLUGS, 19 AND 20 GAUGE

Plug, Scleral

OPHTHALMIC CONSULTANTS, INC.

The following data is part of a premarket notification filed by Ophthalmic Consultants, Inc. with the FDA for Scleral Plugs, 19 And 20 Gauge.

Pre-market Notification Details

Device IDK990872
510k NumberK990872
Device Name:SCLERAL PLUGS, 19 AND 20 GAUGE
ClassificationPlug, Scleral
Applicant OPHTHALMIC CONSULTANTS, INC. 65 N. MAIN, SUITE 101 PO BOX 154 Tooele,  UT  84074
ContactJohn E Lincoln
CorrespondentJohn E Lincoln
OPHTHALMIC CONSULTANTS, INC. 65 N. MAIN, SUITE 101 PO BOX 154 Tooele,  UT  84074
Product CodeLXP  
CFR Regulation Number886.4155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-03-16
Decision Date1999-07-13
Summary:summary

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