FDA 510(k) Application Details - K992483

Device Classification Name Cystoscope And Accessories, Flexible/Rigid

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510(K) Number K992483
Device Name Cystoscope And Accessories, Flexible/Rigid
Applicant MEDIFIX, INC.
8727 NARRAGANSETT
MORTON GROVE, IL 60053-0000 US
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Contact GEORGE ALBULESCU
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Regulation Number 876.1500

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Classification Product Code FAJ
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Date Received 07/26/1999
Decision Date 08/30/1999
Decision SESE - SUBST EQUIV
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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