FDA 510(k) Application Details - K992930

Device Classification Name Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

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510(K) Number K992930
Device Name Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Applicant BIOTEQUE CORP.
900 N. SWITZER CANYON DR. #142
FLAGSTAFF, AZ 86001 US
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Contact ALLEN REICH
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Regulation Number 876.5820

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Classification Product Code FJK
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Date Received 08/31/1999
Decision Date 02/09/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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