FDA 510(k) Application Details - K760897

Device Classification Name Catheter, Urological

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510(K) Number K760897
Device Name Catheter, Urological
Applicant DIAMED DIVISION ILL. TOOL WORKS, INC.

, US
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Regulation Number 876.5130

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Classification Product Code KOD
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Date Received 10/26/1976
Decision Date 08/31/1978
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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