510(k) K100780

VITAL SUTURES, SUTUREX, CIRUGIA PERUANA by Unilene Sac — Product Code NEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2010
Date Received
March 19, 2010
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