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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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