FDA 510(k) Application Details - K041453

Device Classification Name Stripper, Vein, External

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510(K) Number K041453
Device Name Stripper, Vein, External
Applicant SMITH & NEPHEW, INC.
150 MINUTEMAN RD.
ANDOVER, MA 01810 US
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Contact KAREN PROVENCHER
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Regulation Number 870.4885

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Classification Product Code DWQ
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Date Received 06/01/2004
Decision Date 07/22/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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