FDA 510(k) Application Details - K940548

Device Classification Name Tubes, Gastrointestinal (And Accessories)

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510(K) Number K940548
Device Name Tubes, Gastrointestinal (And Accessories)
Applicant MEDICAL INNOVATIONS CORP.
1595 MC-CANDLESS DR.
MILPITAS, CA US
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Contact DENNIS L WONG
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Regulation Number 876.5980

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Classification Product Code KNT
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Date Received 02/07/1994
Decision Date 02/22/1995
Decision SE - Substantially Equivalent
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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