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510(k) K021767

ASSUFIL by Assut Europe S.P.A. — Product Code GAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2002
Date Received
May 29, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class
Class II
Regulation Number
878.4493
Review Panel
SU
Submission Type

Other clearances by Assut Europe S.P.A.

  • K171039 — Assut Filbloc Permanent Sutures (August 29, 2017)
  • K150553 — Filbloc (May 19, 2016)

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