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FDA 510(k) Application Details - K964959
Device Classification Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
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510(K) Number
K964959
Device Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
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
870.3450
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Classification Product Code
DSY
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More FDA Info for this Product Code
Date Received
12/11/1996
Decision Date
03/10/1997
Decision
ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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