FDA 510(k) Application Details - K030836

Device Classification Name

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510(K) Number K030836
Device Name D-STAT-DRY HEMOSTATIC BANDAGE; D-STAT RADIAL HEMOSTATIC BANDAGE
Applicant VASCULAR SOLUTIONS, INC.
2495 XENIUM LN. NORTH
MINNEAPOLIS, MN 55441 US
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Contact DEBORAH JENSEN
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Regulation Number

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Classification Product Code QSX
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Date Received 03/17/2003
Decision Date 09/17/2003
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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