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510(k) K190245

PDS Barbed Suture, PDO MAXX Threads by Pdo Max, Inc. — Product Code NEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2019
Date Received
February 6, 2019
Clearance Type
Abbreviated
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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