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510(k) K201934

Surgimatix Absorbable Fixation System by Surgimatix, Inc. — Product Code GDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 2021
Date Received
July 13, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Implantable
Device Class
Class II
Regulation Number
878.4750
Review Panel
SU
Submission Type

Other clearances by Surgimatix, Inc.

  • K132669 — PROXIFAST ABSORBABLE STAPLE (January 13, 2014)

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