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510(k) K211178

DURAMESH Mesh Suture by Msi — Product Code GAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2022
Date Received
April 20, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class
Class II
Regulation Number
878.5010
Review Panel
SU
Submission Type

Other clearances by Msi

  • K960200 — INTROSTAT LEAD INTRODUCER (July 2, 1996)
  • K944226 — MSI PROCEDURE KIT (June 21, 1995)

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