510(k) K012124

MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP by Johnson & Johnson Medical (China) , Ltd. — Product Code GAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2001
Date Received
July 6, 2001
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