FDA 510(k) Application Details - K160854

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyethylene   More FDA Info for this Device
510(K) Number	K160854
Device Name	Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant	Biomet Manafacturing Corp. 56 East Bell Drive PO Box 587 Warsaw, IN 46581 US Other 510(k) Applications for this Company
Contact	Adam Cargill Other 510(k) Applications for this Contact
Regulation Number	878.5000   More FDA Info for this Regulation Number
Classification Product Code	GAT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/28/2016
Decision Date	12/19/2016
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