FDA 510(k) Application Details - K771420

Device Classification Name Catheter, Peritoneal, Long-Term Indwelling

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510(K) Number K771420
Device Name Catheter, Peritoneal, Long-Term Indwelling
Applicant QUINTON, INC.

, US
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Regulation Number 876.5630

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Classification Product Code FJS
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Date Received 08/01/1977
Decision Date 11/28/1977
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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