SUNDER CENTRAL VENOUS CATHETER KIT, MODELS SD-3L55F30J AND SD-3L70F30J


Device Classification Name

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

510(k) Number K024007
Device Name SUNDER CENTRAL VENOUS CATHETER KIT, MODELS SD-3L55F30J AND SD-3L70F30J
Original Applicant
SUNDER BIOMEDICAL TECH. CO., LTD.
10f-1, 1-67, wu-chuan rd.
taichung city, 

TW

403

Original Contact tony hung
Regulation Number 880.5200
Classification Product Code
FOZ  
Date Received 12/04/2002
Decision Date 07/14/2003
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