D-Stat Radial Topical Hemostat

Dressing, Wound, Drug

Vascular Solutions LLC

The following data is part of a premarket notification filed by Vascular Solutions Llc with the FDA for D-stat Radial Topical Hemostat.

Pre-market Notification Details

Device IDK200720
510k NumberK200720
Device Name:D-Stat Radial Topical Hemostat
ClassificationDressing, Wound, Drug
Applicant Vascular Solutions LLC 6401 Sycamore Ct N Maple Grove,  MN  55369
ContactIroquois Ledbeter
CorrespondentMelissa Sommerfeld
Vascular Solutions LLC 6401 Sycamore Ct N Maple Grove,  MN  55369
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductYes
Date Received2020-03-19
Decision Date2020-06-26

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