FDA 510(k) Application Details - K060741

Device Classification Name Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

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510(K) Number K060741
Device Name Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant VERYAN MEDICAL LIMITED
1327 BLUEGRASS WAY
GAMBRILLS, MD 21054 US
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Contact SEMITH OKTAY
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Regulation Number 870.3450

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Classification Product Code DSY
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Date Received 03/20/2006
Decision Date 04/05/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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