510(k) K130191

MINT by Hans Biomed Corporation — Product Code NEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2013
Date Received
January 25, 2013
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