FDA 510(k) Application Details - K170897

Device Classification Name	More FDA Info for this Device
510(K) Number	K170897
Device Name	Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site
Applicant	B. Braun Medical Inc. 901 Marcon Blvd. Allentown, PA 18109 US Other 510(k) Applications for this Company
Contact	Angela J. Caravella Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PTI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/27/2017
Decision Date	11/03/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review