FDA 510(k) Application Details - K043203

Device Classification Name Tubes, Gastrointestinal (And Accessories)

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510(K) Number K043203
Device Name Tubes, Gastrointestinal (And Accessories)
Applicant WILSON-COOK MEDICAL, INC.
4900 BETHANIA STATION RD.
WINSTON-SALEM, NC 27105 US
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Contact MARGE WALLS-WALKER
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Regulation Number 876.5980

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Classification Product Code KNT
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Date Received 11/18/2004
Decision Date 05/11/2005
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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