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510(k) K130016

LIFESPAN EPTFE VASCULAR GRAFT by LeMaitre Vascular, Inc. — Product Code DSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2013
Date Received
January 1, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device Class
Class II
Regulation Number
870.3450
Review Panel
CV
Submission Type

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