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FDA 510(k) Application Details - K200955
Device Classification Name
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
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510(K) Number
K200955
Device Name
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Applicant
Vascutek Ltd
Newmains Avenue
Inchinnan PA4 9RR GB
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Contact
Heidi Forsyth
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Regulation Number
870.3470
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Classification Product Code
DXZ
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More FDA Info for this Product Code
Date Received
04/09/2020
Decision Date
07/08/2020
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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