FDA 510(k) Application Details - K061021

Device Classification Name Tubes, Gastrointestinal (And Accessories)

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510(K) Number K061021
Device Name Tubes, Gastrointestinal (And Accessories)
Applicant CONMED CORP.
129 CONCORD ROAD
BUILDING 3
BILLERICA, MA 01821 US
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Contact BETH A ZIS
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Regulation Number 876.5980

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Classification Product Code KNT
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Date Received 04/13/2006
Decision Date 04/28/2006
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 Y
Expedited Review



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