D-STAT DRY CLEAR HEMOSTATIC BANDAGE, MODEL 3005

Dressing, Wound, Drug

VASCULAR SOLUTIONS, INC.

The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for D-stat Dry Clear Hemostatic Bandage, Model 3005.

Pre-market Notification Details

Device IDK073264
510k NumberK073264
Device Name:D-STAT DRY CLEAR HEMOSTATIC BANDAGE, MODEL 3005
ClassificationDressing, Wound, Drug
Applicant VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis,  MN  55369
ContactJames Chapman
CorrespondentJames Chapman
VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis,  MN  55369
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductYes
Date Received2007-11-20
Decision Date2007-12-07
Summary:summary

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