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FDA 510(k) Application Details - K960766
Device Classification Name
Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
More FDA Info for this Device
510(K) Number
K960766
Device Name
Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
Applicant
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
112 BAUER DR.
OAKLAND, NJ 07436 US
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Contact
STEPHEN B ANDERSON
Other 510(k) Applications for this Contact
Regulation Number
870.3450
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Classification Product Code
DYF
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More FDA Info for this Product Code
Date Received
02/26/1996
Decision Date
03/19/1997
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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