FDA 510(k) Application Details - K990365

Device Classification Name Tubes, Gastrointestinal (And Accessories)

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510(K) Number K990365
Device Name Tubes, Gastrointestinal (And Accessories)
Applicant T-MED VAC CORPORATION
24 LAKEWOOD DR.
RACINE, WI 53402 US
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Contact LANIS P PFOLSGROF
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Regulation Number 876.5980

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Classification Product Code KNT
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Date Received 02/05/1999
Decision Date 07/26/2000
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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