FDA 510(k) Application Details - K092049

Device Classification Name Tubes, Gastrointestinal (And Accessories)

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510(K) Number K092049
Device Name Tubes, Gastrointestinal (And Accessories)
Applicant SAINATH INTELLECTUAL PROPERTIES, LLC
501 E KENNEDY BLVD.
SUITE 1700
TAMPA, FL 33602 US
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Contact CHRISTOPHER PARADIES
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Regulation Number 876.5980

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Classification Product Code KNT
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Date Received 07/07/2009
Decision Date 10/09/2009
Decision SESK - SUBST EQUIV - KIT
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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