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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Fistula
510(k) Number K112734
Device Name APLAN A.V. FISTULA NEEDLE SET
Applicant
APLAN WELL ENTERPRISE CO., LTD
NO. 58, FU CHIUN STREET
HSIN CHU CITY,  TW 30067
Applicant Contact JEN KE-MIN
Correspondent
APLAN WELL ENTERPRISE CO., LTD
NO. 58, FU CHIUN STREET
HSIN CHU CITY,  TW 30067
Correspondent Contact JEN KE-MIN
Regulation Number876.5540
Classification Product Code
FIE  
Date Received09/20/2011
Decision Date 04/24/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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