FDA 510(k) Application Details - K200720

Device Classification Name

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510(K) Number K200720
Device Name D-Stat Radial Topical Hemostat
Applicant Vascular Solutions LLC
6401 Sycamore Ct N
Maple Grove, MN 55369 US
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Contact Iroquois Ledbeter
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Regulation Number

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Classification Product Code QSX
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Date Received 03/19/2020
Decision Date 06/26/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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