FDA 510(k) Application Details - K013523

Device Classification Name	Set, I.V. Fluid Transfer   More FDA Info for this Device
510(K) Number	K013523
Device Name	Set, I.V. Fluid Transfer
Applicant	SHIRE BIOLOGICS INC. WORLDWIDE REGULATORY AFFAIRS 10182 TELESIS COURT SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	ANGELA ROGERS 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	10/23/2001
Decision Date	01/07/2002
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