FDA 510(k) Application Details - K981860

Device Classification Name	Device, Intravascular Catheter Securement   More FDA Info for this Device
510(K) Number	K981860
Device Name	Device, Intravascular Catheter Securement
Applicant	PARAWORKS ENTERPRISE, LTD. #1-179 WEST 17TH AVENUE VANCOUVER, BRITISH COLUMBIA V57 1Z7 CA Other 510(k) Applications for this Company
Contact	MICHAEL C CAMPBELL Other 510(k) Applications for this Contact
Regulation Number	880.5210   More FDA Info for this Regulation Number
Classification Product Code	KMK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/27/1998
Decision Date	06/03/1999
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