FDA 510(k) Application Details - K180417

Device Classification Name	Syringe, Antistick   More FDA Info for this Device
510(K) Number	K180417
Device Name	Syringe, Antistick
Applicant	BERPU MEDICAL TECHNOLOGY CO., LTD NO. 14 Xingji Road, Yongxing Street, Longwan District Wenzhou 325000 CN Other 510(k) Applications for this Company
Contact	Jundong Tan Other 510(k) Applications for this Contact
Regulation Number	880.5860   More FDA Info for this Regulation Number
Classification Product Code	MEG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/15/2018
Decision Date	08/09/2018
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