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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact SHERRY LIN
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received09/01/2011
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
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