FDA 510(k) Application Details - K081060

Device Classification Name	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile   More FDA Info for this Device
510(K) Number	K081060
Device Name	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Applicant	CORE ESSENCE ORTHOPAEDICS, LLC 301 OXFORD VALLEY RD. SUITE 905B YARDLEY, PA 19067 US Other 510(k) Applications for this Company
Contact	SHAWN T HUXEL Other 510(k) Applications for this Contact
Regulation Number	878.4495   More FDA Info for this Regulation Number
Classification Product Code	GAQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/14/2008
Decision Date	12/24/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review