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510(k) K210871

PDO Max Suture with Dual Needle by Pdo Max, Inc. — Product Code NEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2021
Date Received
March 24, 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

Other clearances by Pdo Max, Inc.

  • K190245 — PDS Barbed Suture, PDO MAXX Threads (June 4, 2019)

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