FDA 510(k) Application Details - K100705

Device Classification Name	Pump, Infusion   More FDA Info for this Device
510(K) Number	K100705
Device Name	Pump, Infusion
Applicant	ZYNO MEDICAL LLC 395 TOTTEN POND RD. SUITE 201 WALTHAM, MA 02451 US Other 510(k) Applications for this Company
Contact	CHAOYOUNG LEE Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	FRN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/12/2010
Decision Date	07/08/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review