UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR


Device Classification Name

set, administration, intravascular

510(k) Number K013949
Device Name UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR
Original Applicant
CHURCHILL MEDICAL SYSTEMS, INC.
87 venture dr.
dover, 
NH 
03820

Original Contact ketih paluch
Regulation Number 880.5440
Classification Product Code
FPA  
Date Received 11/30/2001
Decision Date 03/27/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No