FDA 510(k) Application Details - K033721

Device Classification Name Syringe, Piston

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510(K) Number K033721
Device Name Syringe, Piston
Applicant VASCULAR SOLUTIONS, INC.
6464 SYCAMORE COURT
MINNEAPOLIS, MN 55369 US
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Contact SARA L COON
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 11/26/2003
Decision Date 02/13/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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