DIAMOND KNIFE

Knife, Ophthalmic

KOI, INC.

The following data is part of a premarket notification filed by Koi, Inc. with the FDA for Diamond Knife.

Pre-market Notification Details

Device IDK830366
510k NumberK830366
Device Name:DIAMOND KNIFE
ClassificationKnife, Ophthalmic
Applicant KOI, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeHNN  
CFR Regulation Number886.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-02-04
Decision Date1983-03-09

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