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510(k) K212380

PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture by Ethicon, Inc. — Product Code NEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2022
Date Received
August 2, 2021
Clearance Type
Traditional
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

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