510(k) K113763

SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE by Nobles Medical Technologies Ii, Inc. — Product Code GAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2012
Date Received
December 21, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class
Class II
Regulation Number
878.5010
Review Panel
SU
Submission Type