Saliva, Artificial

SunBio, Inc.

The following data is part of a premarket notification filed by Sunbio, Inc. with the FDA for Mucopeg.

Pre-market Notification Details

Device IDK190144
501k NumberK190144
Device Name:MucoPEG
ClassificationSaliva, Artificial
Applicant SunBio, Inc. 95 Sanbon-ro Gunpo-si,  KR 15849
ContactSun S. Kim
CorrespondentStuart R. Goldman
Emergo By UL 2500 Bee Cave Road; Bldg. 1, Suite 300 Austin,  TX  78746
Product CodeLFD  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical Specialty510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
501k Review PanelDental
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-01-29
Decision Date2019-11-05

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