FDA 510(k) Application Details - K771891

Device Classification Name Catheter, Umbilical Artery

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510(K) Number K771891
Device Name Catheter, Umbilical Artery
Applicant TRAVENOL LABORATORIES, S.A.

, US
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Regulation Number 880.5200

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Classification Product Code FOS
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Date Received 10/06/1977
Decision Date 11/02/1977
Decision SE - Substantially Equivalent
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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