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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 K993118
Device Name BIOTEQUE A.V. FISTULA NEEDLE SET
Applicant
Bioteque Corp.
900 N. Switzer Canyon Dr. #142
Flaggstaff,  AZ  86001
Applicant Contact ALLEN REICH
Correspondent
Bioteque Corp.
900 N. Switzer Canyon Dr. #142
Flaggstaff,  AZ  86001
Correspondent Contact ALLEN REICH
Regulation Number876.5540
Classification Product Code
FIE  
Date Received09/20/1999
Decision Date 12/17/1999
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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