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510(k) K192490

Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch by Teleflex Medical — Product Code GAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2020
Date Received
September 11, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class
Class II
Regulation Number
878.5000
Review Panel
SU
Submission Type

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