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510(k) K200392

REXSIN by Sm Eng Co., Ltd. — Product Code GAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 2020
Date Received
February 18, 2020
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 Sm Eng Co., Ltd.

  • K173747 — REXLENE (December 21, 2018)
  • K173779 — REXMONO, PDREX (March 12, 2018)
  • K161633 — REXLON, REXSIL (March 2, 2017)
  • K161629 — CRYLREX (February 10, 2017)

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