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510(k) K150553

Filbloc by Assut Europe — Product Code NEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2016
Date Received
March 4, 2015
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 Assut Europe

  • K171039 — Assut Filbloc Permanent Sutures (August 29, 2017)
  • K021767 — ASSUFIL (November 19, 2002)

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