Chitogel Endoscopic Sinus Surgery Kit

Splint, Intranasal Septal

Chitogel Ltd

The following data is part of a premarket notification filed by Chitogel Ltd with the FDA for Chitogel Endoscopic Sinus Surgery Kit.

Pre-market Notification Details

Device IDK172179
510k NumberK172179
Device Name:Chitogel Endoscopic Sinus Surgery Kit
ClassificationSplint, Intranasal Septal
Applicant Chitogel Ltd 139 Moray Place Dunedin,  NZ 9016
ContactCaty Spencer
CorrespondentGregory Mathison
Regulatory Strategies, Inc 3924 Cascade Beach Road Lutsen,  MN  55612
Product CodeLYA  
CFR Regulation Number874.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-19
Decision Date2017-10-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
09400998100040 K172179 000

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