510(k) K060528

AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE by Aesculap, Inc. — Product Code GAR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2006
Date Received
February 28, 2006
Clearance Type
Special
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