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510(k) K171039

Assut Filbloc Permanent Sutures by Assut Europe S.P.A. — Product Code GAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2017
Date Received
April 6, 2017
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class
Class II
Regulation Number
878.5010
Review Panel
SU
Submission Type

Other clearances by Assut Europe S.P.A.

  • K150553 — Filbloc (May 19, 2016)
  • K021767 — ASSUFIL (November 19, 2002)

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