KERATOME SYSTEM, MODEL K3000

Keratome, Battery-powered

INSIGHT TECHNOLOGIES INSTRUMENTS, LLC.

The following data is part of a premarket notification filed by Insight Technologies Instruments, Llc. with the FDA for Keratome System, Model K3000.

Pre-market Notification Details

Device IDK984537
510k NumberK984537
Device Name:KERATOME SYSTEM, MODEL K3000
ClassificationKeratome, Battery-powered
Applicant INSIGHT TECHNOLOGIES INSTRUMENTS, LLC. 264 QUARRY RD. Milford,  CT  06460
ContactCharles Vassallo
CorrespondentCharles Vassallo
INSIGHT TECHNOLOGIES INSTRUMENTS, LLC. 264 QUARRY RD. Milford,  CT  06460
Product CodeHMY  
CFR Regulation Number886.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-12-21
Decision Date1999-05-14

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