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510(k) K181582

DemeTECH DemeDIOX absorbable surgical suture by Demetech Corporation — Product Code NEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2018
Date Received
June 15, 2018
Clearance Type
Special
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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  • K190777 — DemeTECH DemeFORCE Nonabsorbable Surgical Suture (July 31, 2019)
  • K181578 — DemeTECH PTFE Nonabsorbable Surgical Suture (October 11, 2018)

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