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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.
# 2-3, Kung 8th Rd.
Second Industrial Park
New Taipei City,  TW 244
Applicant Contact SHERRY LIN
Correspondent
Yomura Technologies, Inc.
# 2-3, Kung 8th Rd.
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
Predetermined Change
Control Plan Authorized		 No
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