510(k) K073614

WG-SURGICAL SUTURES WITH NEEDLE by Foosin Medical Supplies, Inc. — Product Code NEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2008
Date Received
December 26, 2007
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