510(k) K223122

MENIX®; MENIX® DUO by S.B.M. Sas (Science & Bio Materials) — Product Code GAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 2023
Date Received
October 3, 2022
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