SPECATH CENTRAL VENOUS CATHETER KITS


Device Classification Name

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

510(k) Number K021130
Device Name SPECATH CENTRAL VENOUS CATHETER KITS
Original Applicant
SPECIAL MEDICAL CO. LTD.
55 northern blvd.
suite 200
great neck, 
NY 
11021

Original Contact susan d goldstein-falk
Regulation Number 880.5200
Classification Product Code
FOZ  
Date Received 04/09/2002
Decision Date 01/07/2003
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