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510(k) K143584

PGA RESORBA, PGA RESOQUICK, GLYCOLON by Resorba Medical GmbH — Product Code GAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 2015
Date Received
December 18, 2014
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 Resorba Medical GmbH

  • K181320 — Caprolon (September 18, 2018)
  • K143582 — MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL (October 29, 2015)
  • K141072 — SUPOLENE (June 23, 2014)

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