Myriad Particles

Dressing, Wound, Collagen

Aroa Biosurgery Ltd.

The following data is part of a premarket notification filed by Aroa Biosurgery Ltd. with the FDA for Myriad Particles.

Pre-market Notification Details

Device IDK200502
510k NumberK200502
Device Name:Myriad Particles
ClassificationDressing, Wound, Collagen
Applicant Aroa Biosurgery Ltd. 2 Kingsford Smith Place Airport Oaks,  NZ 2022
ContactTina O'brien
CorrespondentTina O'brien
Aroa Biosurgery Ltd. 2 Kingsford Smith Place Airport Oaks,  NZ 2022
Product CodeKGN  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-28
Decision Date2021-03-31

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