FDA 510(k) Application Details - K973409

Device Classification Name Tubes, Gastrointestinal (And Accessories)

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510(K) Number K973409
Device Name Tubes, Gastrointestinal (And Accessories)
Applicant DAVIS & GECK, INC.
444 MC DONNELL BLVD.
HAZELWOOD, MO 63042 US
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Contact VANADA JOHNSON
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Regulation Number 876.5980

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Classification Product Code KNT
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Date Received 09/09/1997
Decision Date 02/27/1998
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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