OCCU-FLO PUNCTUM PLUGS

Plug, Punctum

U.S. IOL, INC.

The following data is part of a premarket notification filed by U.s. Iol, Inc. with the FDA for Occu-flo Punctum Plugs.

Pre-market Notification Details

Device IDK001768
510k NumberK001768
Device Name:OCCU-FLO PUNCTUM PLUGS
ClassificationPlug, Punctum
Applicant U.S. IOL, INC. 2500 SANDERSVILLE RD. Lexington,  KY  40511
ContactTeresa Burton
CorrespondentTeresa Burton
U.S. IOL, INC. 2500 SANDERSVILLE RD. Lexington,  KY  40511
Product CodeLZU  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-06-12
Decision Date2000-09-19

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