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510(k) K191361

DemeDIOX Barbed Absorbable Surgical Suture by Demetech Corporation — Product Code NEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2019
Date Received
May 21, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Surgical, Absorbable, Polydioxanone
Device Class
Class II
Regulation Number
878.4840
Review Panel
SU
Submission Type

Other clearances by Demetech Corporation

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  • K181578 — DemeTECH PTFE Nonabsorbable Surgical Suture (October 11, 2018)
  • K181582 — DemeTECH DemeDIOX absorbable surgical suture (August 27, 2018)

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