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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
510(k) Number K013634
Device Name BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK
Applicant
BIOTEQUE CORP.
3892 SOUTH AMERICA WEST TRAIL
FLAGGSTAFF,  AZ  86001
Applicant Contact JENNIFER REICH
Correspondent
BIOTEQUE CORP.
3892 SOUTH AMERICA WEST TRAIL
FLAGGSTAFF,  AZ  86001
Correspondent Contact JENNIFER REICH
Regulation Number876.5820
Classification Product Code
FJK  
Date Received11/05/2001
Decision Date 07/09/2002
Decision Substantially Equivalent - Kit (SESK)
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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