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FDA 510(k) Application Details - K012952
Device Classification Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
More FDA Info for this Device
510(K) Number
K012952
Device Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant
BOSTON SCIENTIFIC/MEDI-TECH
ONE BOSTON SCIENTIFIC PLACE
NATICK, MA 01760-1537 US
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Contact
JENNIFER BOLTON
Other 510(k) Applications for this Contact
Regulation Number
870.3450
More FDA Info for this Regulation Number
Classification Product Code
DSY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/04/2001
Decision Date
10/02/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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