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510(k) K190777

DemeTECH DemeFORCE Nonabsorbable Surgical Suture by Demetech Corporation — Product Code GAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2019
Date Received
March 26, 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

Other clearances by Demetech Corporation

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  • K181582 — DemeTECH DemeDIOX absorbable surgical suture (August 27, 2018)

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