FDA 510(k) Application Details - K061219

Device Classification Name

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510(K) Number K061219
Device Name D-STAT DRY HEMOSTATIC BANDAGE
Applicant VASCULAR SOLUTIONS, INC.
6464 SYCAMORE COURT
MINNEAPOLIS, MN 55369 US
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Contact JULIE TAPPER
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Regulation Number

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Classification Product Code QSX
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Date Received 05/01/2006
Decision Date 10/06/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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