510(k) K080684

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2008
Date Received
March 10, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Silk
Device Class
Class II
Regulation Number
878.5030
Review Panel
SU
Submission Type