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510(k) K220549

MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014 by Hans Biomed Corporation — Product Code NEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2023
Date Received
February 25, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Surgical, Absorbable, Polydioxanone
Device Class
Class II
Regulation Number
878.4840
Review Panel
SU
Submission Type

Other clearances by Hans Biomed Corporation

  • K192423 — MINT Product Family (September 9, 2020)
  • K171568 — SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty (February 22, 2018)
  • K130191 — MINT (June 12, 2013)

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