Axiostat Patch

Dressing, Wound, Drug

Advamedica Inc.

The following data is part of a premarket notification filed by Advamedica Inc. with the FDA for Axiostat Patch.

Pre-market Notification Details

Device IDK202830
510k NumberK202830
Device Name:Axiostat Patch
ClassificationDressing, Wound, Drug
Applicant Advamedica Inc. Harvard Square, 1 Mifflin Place, Suite 400 Cambridge,  MA  02138
ContactLeo Mavely
CorrespondentAlan Donald
Matrix Medical Consulting, Inc. 8880 Rio San Diego Drive, Suite 800 San Diego,  CA  92108
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-25
Decision Date2021-04-15

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