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510(k) K173779

REXMONO, PDREX by Sm Eng Co., Ltd. — Product Code GAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2018
Date Received
December 12, 2017
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.

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

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