0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE


codes

Device Classification Name

catheter,intravascular,therapeutic,short-term less than 30 days

510(k) Number K000632
Device Name 0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE
Original Applicant
AVITRO LLC.
2200 lake shore dr.
woodstock, 
IL 
60098

Original Contact john brda
Regulation Number 880.5200
Classification Product Code
FOZ  
Date Received 02/24/2000
Decision Date 10/19/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No