FDA 510(k) Application Details - K990389

Device Classification Name Tubes, Gastrointestinal (And Accessories)

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510(K) Number K990389
Device Name Tubes, Gastrointestinal (And Accessories)
Applicant MOSS TUBES, INC.
304 VERONA AVE.
ELIZABETH, NJ 07208 US
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Contact HARRY SCHLAKMAN
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Regulation Number 876.5980

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Classification Product Code KNT
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Date Received 02/08/1999
Decision Date 03/22/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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