FDA 510(k) Application Details - K151009

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyethylene   More FDA Info for this Device
510(K) Number	K151009
Device Name	Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant	BAYLIS MEDICAL COMPANY INC. 2645 MATHESON BLVD. EAST MISSISSAUGA L4W 5S4 CA Other 510(k) Applications for this Company
Contact	Meghal Khakhar 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	04/15/2015
Decision Date	08/18/2015
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