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510(k) K201479

DemeMASK by Demetech Corporation — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2020
Date Received
June 4, 2020
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by Demetech Corporation

  • K191361 — DemeDIOX Barbed Absorbable Surgical Suture (November 7, 2019)
  • K190777 — DemeTECH DemeFORCE Nonabsorbable Surgical Suture (July 31, 2019)
  • K181578 — DemeTECH PTFE Nonabsorbable Surgical Suture (October 11, 2018)
  • K181582 — DemeTECH DemeDIOX absorbable surgical suture (August 27, 2018)

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