510(k) K031443

LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS by Lsi Solutions — Product Code NEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2003
Date Received
May 6, 2003
Clearance Type
Abbreviated
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