Sterile NS System

Plate, Cranioplasty, Preformed, Alterable

Jeil Medical Corporation

The following data is part of a premarket notification filed by Jeil Medical Corporation with the FDA for Sterile Ns System.

Pre-market Notification Details

Device IDK170368
510k NumberK170368
Device Name:Sterile NS System
ClassificationPlate, Cranioplasty, Preformed, Alterable
Applicant Jeil Medical Corporation 55 Digital-ro, 34-gil 702, 703, 704, 705, 706, 804, 805, 807, 812-ho Seoul,  KR 152-728
ContactSeungyong Lee
CorrespondentJi Won Song
Jeil Medical Corporation 55 Digital-ro, 34-gil 702, 703, 704, 705, 706, 804, 805, 807, 812-ho Seoul,  KR 152-728
Product CodeGWO  
Subsequent Product CodeGXR
Subsequent Product CodeHBW
CFR Regulation Number882.5320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-02-06
Decision Date2017-09-11
Summary:summary

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