FDA 510(k) Application Details - K162617

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polypropylene   More FDA Info for this Device
510(K) Number	K162617
Device Name	Suture, Nonabsorbable, Synthetic, Polypropylene
Applicant	NOBLES MEDICAL TECHNOLOGIES II, INC. 17074 NEWHOPE ST. FOUNTAIN VALLEY, CA 92708 US Other 510(k) Applications for this Company
Contact	FAYE DUNN Other 510(k) Applications for this Contact
Regulation Number	878.5010   More FDA Info for this Regulation Number
Classification Product Code	GAW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/20/2016
Decision Date	04/06/2017
Decision	SESU - SE - WITH LIMITATIONS
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