Vascette HP (hemostatic Pad)

Dressing, Wound, Drug

KOAG LLC

The following data is part of a premarket notification filed by Koag Llc with the FDA for Vascette Hp (hemostatic Pad).

Pre-market Notification Details

Device IDK220566
510k NumberK220566
Device Name:Vascette HP (hemostatic Pad)
ClassificationDressing, Wound, Drug
Applicant KOAG LLC 790 Rarity Bay Pkwy Vonore,  TN  37885
ContactDavid Lang
CorrespondentDavid Lang
KOAG LLC 790 Rarity Bay Pkwy Vonore,  TN  37885
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-28
Decision Date2022-07-29

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.