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510(k) K212810

MONOFIX PGCL, knotless wound closure device by Samyang Holdings Corp., Ltd. — Product Code GAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 2022
Date Received
September 3, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class
Class II
Regulation Number
878.4493
Review Panel
SU
Submission Type

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