510(k) K151165

Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture by Aesculap, Inc. — Product Code GAR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 2016
Date Received
May 1, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyamide
Device Class
Class II
Regulation Number
878.5020
Review Panel
SU
Submission Type