510(k) K051609

QUILL SYNTHETIC ABSORBABLE BARBED SUTURE by Quill Medical, Inc. — Product Code NEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2005
Date Received
June 17, 2005
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