ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100

Endoilluminator

ISCIENCE SURGICAL

The following data is part of a premarket notification filed by Iscience Surgical with the FDA for Iscience Surgical Fiberoptic Illuminator, Model Fi - 100.

Pre-market Notification Details

Device IDK062259
510k NumberK062259
Device Name:ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100
ClassificationEndoilluminator
Applicant ISCIENCE SURGICAL 4055 CAMPBELL AVENUE Menlo Park,  CA  94025
ContactGrace Bartoo
CorrespondentNeil E Devine Jr
INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg,  OH  44087
Product CodeMPA  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2006-08-04
Decision Date2006-08-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00893872001073 K062259 000
00893872001608 K062259 000

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