FDA 510(k) Application Details - K121637

Device Classification Name	Syringe, Antistick   More FDA Info for this Device
510(K) Number	K121637
Device Name	Syringe, Antistick
Applicant	SUNWELL BIOTECH CO., LTD 77325 JOYCE WAY ECHO, OR 97826 US Other 510(k) Applications for this Company
Contact	CHARLIE MACK 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	06/04/2012
Decision Date	10/25/2012
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