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FDA 510(k) Application Details - K963611
Device Classification Name
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
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510(K) Number
K963611
Device Name
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Applicant
VASCUTEK LTD.
1300 EAST ANDERSON LN.
AUSTIN, TX 78752 US
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Contact
TEENA M AUGOSTINO
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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
09/10/1996
Decision Date
11/21/1996
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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