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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemostatic Wound Dressing With Thrombin Or Other Biologics
510(k) Number K200720
Device Name D-Stat Radial Topical Hemostat
Applicant
Vascular Solutions, LLC
6401 Sycamore Ct N
Maple Grove,  MN  55369
Applicant Contact Iroquois Ledbeter
Correspondent
Vascular Solutions, LLC
6401 Sycamore Ct N
Maple Grove,  MN  55369
Correspondent Contact Melissa Sommerfeld
Classification Product Code
QSX  
Date Received03/19/2020
Decision Date 06/26/2020
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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