OPTHALMIC SURGICAL INSTRUMENTS

Cannula, Ophthalmic

TRIDAK DIVISION OF INDICON, INC.

The following data is part of a premarket notification filed by Tridak Division Of Indicon, Inc. with the FDA for Opthalmic Surgical Instruments.

Pre-market Notification Details

Device IDK860744
510k NumberK860744
Device Name:OPTHALMIC SURGICAL INSTRUMENTS
ClassificationCannula, Ophthalmic
Applicant TRIDAK DIVISION OF INDICON, INC. ONE BLUE HILL PLAZA SUITE 815 Pearl River,  NY  10965
ContactCorinne M Ambrosino
CorrespondentCorinne M Ambrosino
TRIDAK DIVISION OF INDICON, INC. ONE BLUE HILL PLAZA SUITE 815 Pearl River,  NY  10965
Product CodeHMX  
CFR Regulation Number886.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-02-27
Decision Date1986-03-31

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