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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stents, Drains And Dilators For The Biliary Ducts
510(k) Number K033862
Device Name BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK
Applicant
Bioteque Corp.
8f-3, # 136, Sec. 3,
Jen-Ai Rd.
Taipei,  TW
Applicant Contact WILLIAM LEE
Correspondent
Bioteque Corp.
8f-3, # 136, Sec. 3,
Jen-Ai Rd.
Taipei,  TW
Correspondent Contact WILLIAM LEE
Regulation Number876.5010
Classification Product Code
FGE  
Subsequent Product Code
LJE  
Date Received12/12/2003
Decision Date 02/14/2005
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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