FDA 510(k) Application Details - K190245

Device Classification Name	Suture, Surgical, Absorbable, Polydioxanone   More FDA Info for this Device
510(K) Number	K190245
Device Name	Suture, Surgical, Absorbable, Polydioxanone
Applicant	PDO MAX, Inc. 4971 Bear Road Liverpool, NY 13088 US Other 510(k) Applications for this Company
Contact	Giovanna McCarthy Other 510(k) Applications for this Contact
Regulation Number	878.4840   More FDA Info for this Regulation Number
Classification Product Code	NEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/06/2019
Decision Date	06/04/2019
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