FDA 510(k) Application Details - K113422

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K113422
Device Name	Needle, Hypodermic, Single Lumen
Applicant	TERUMO (PHILIPPINES) CORPORATION #124 EAST MAIN AVE. LAGUNA TECHNOPARK BINAN, LAGUNA 4026 PH Other 510(k) Applications for this Company
Contact	SANDI HARTKA Other 510(k) Applications for this Contact
Regulation Number	880.5570   More FDA Info for this Regulation Number
Classification Product Code	FMI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/2011
Decision Date	03/05/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review