FDA 510(k) Application Details - K954729

Device Classification Name	Introducer, Syringe Needle   More FDA Info for this Device
510(K) Number	K954729
Device Name	Introducer, Syringe Needle
Applicant	SCANDINAVIAN HEALTH LTD. 700 THIRTEEENTH STREET, N.W. SUITE 1200 WASHINGTON, DC 20005 US Other 510(k) Applications for this Company
Contact	THOMAS SCARLETT Other 510(k) Applications for this Contact
Regulation Number	880.6920   More FDA Info for this Regulation Number
Classification Product Code	KZH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/13/1995
Decision Date	01/29/1996
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