FDA 510(k) Application Details - K012189

Device Classification Name	Set, I.V. Fluid Transfer   More FDA Info for this Device
510(K) Number	K012189
Device Name	Set, I.V. Fluid Transfer
Applicant	ANGIPLAST PRIVATE LTD. 4803, PHASE IV, G.I.D.C., VATVA AHMEDABAD 382 445 IN Other 510(k) Applications for this Company
Contact	ASHIT B SHAH Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	LHI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/12/2001
Decision Date	03/05/2002
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