ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA

Endoilluminator

ISCIENCE SURGICAL CORPORATION

The following data is part of a premarket notification filed by Iscience Surgical Corporation with the FDA for Iscience Surgical Ophthalmic Microcannula.

Pre-market Notification Details

Device IDK041108
510k NumberK041108
Device Name:ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA
ClassificationEndoilluminator
Applicant ISCIENCE SURGICAL CORPORATION 2 DELPHINUS Irvine,  CA  92612
ContactJudy F Gordon
CorrespondentJudy F Gordon
ISCIENCE SURGICAL CORPORATION 2 DELPHINUS Irvine,  CA  92612
Product CodeMPA  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-04-28
Decision Date2004-06-22
Summary:summary

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