YOMURA SAFETY I.V. CATHETER


Device Classification Name

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

510(k) Number K112542
Device Name YOMURA SAFETY I.V. CATHETER
Applicant
YOMURA TECHNOLOGIES INC.
no. 2-3, kung 8th road
second industrial park
new taipei city, 

TW

244

Applicant Contact sherry lin
Correspondent
YOMURA TECHNOLOGIES INC.
no. 2-3, kung 8th road
second industrial park
new taipei city, 

TW

244

Correspodent Contact sherry lin
Regulation Number 880.5200
Classification Product Code
FOZ  
Date Received 09/01/2011
Decision Date 02/08/2012
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