KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS INFUSION SETS.


Device Classification Name

port & catheter, implanted, subcutaneous, intravascular

510(k) Number K022110
Device Name KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS INFUSION SETS.
Original Applicant
KAWASUMI LABORATORIES, INC.
1800 massachusetts ave n.w.
suite 200
washington, 
DC 
20036

Original Contact donald r stone
Regulation Number 880.5965
Classification Product Code
LJT  
Subsequent Product Code
FMI  
Date Received 06/28/2002
Decision Date 09/12/2002
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