WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR


Device Classification Name

set, administration, intravascular

510(k) Number K023917
Device Name WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR
Original Applicant
KAWASUMI LABORATORIES, INC.
1800 massachusetts ave.
n.w. suite 200
washington, 
DC 
20036

Original Contact donald r stone
Regulation Number 880.5440
Classification Product Code
FPA  
Date Received 11/25/2002
Decision Date 02/26/2003
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