MucoLock Oral Gel

Oral Wound Dressing

PCCA, Inc.

The following data is part of a premarket notification filed by Pcca, Inc. with the FDA for Mucolock Oral Gel.

Pre-market Notification Details

Device IDK203091
510k NumberK203091
Device Name:MucoLock Oral Gel
ClassificationOral Wound Dressing
Applicant PCCA, Inc. 9901 S. Wilcrest Drive Houston,  TX  77099
ContactGus Bassani
CorrespondentGus Bassani
PCCA, Inc. 9901 S. Wilcrest Drive Houston,  TX  77099
Product CodeOLR  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-13
Decision Date2021-02-12

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