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510(k) K141206

EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM by Edwards Lifesciences, LLC — Product Code GAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2015
Date Received
May 9, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class
Class II
Regulation Number
878.5010
Review Panel
SU
Submission Type

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