FDA 510(k) Application Details - K760781

Device Classification Name Intracatheter, Dialysis

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510(K) Number K760781
Device Name Intracatheter, Dialysis
Applicant EXTRACORPOREAL MEDICAL SPECIALITIES, INC.

, US
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Regulation Number 876.5820

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Classification Product Code FJT
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Date Received 10/05/1976
Decision Date 12/06/1976
Decision SE - Substantially Equivalent
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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