FDA 510(k) Application Details - K053637

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyamide   More FDA Info for this Device
510(K) Number	K053637
Device Name	Suture, Nonabsorbable, Synthetic, Polyamide
Applicant	MANI, INC. 1301K STREET, N.W. SUITE 1100 - EAST TOWER WASHINGTON, DC 20005-3373 US Other 510(k) Applications for this Company
Contact	DAVID J BLOCH Other 510(k) Applications for this Contact
Regulation Number	878.5020   More FDA Info for this Regulation Number
Classification Product Code	GAR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/29/2005
Decision Date	05/19/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review