FDA 510(k) Application Details - K023019

Device Classification Name Catheter, Urethrographic, Male

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510(K) Number K023019
Device Name Catheter, Urethrographic, Male
Applicant VOMED VOLZER MEDIZINTECHNIK GMBH & CO.
152B BRIDGE ST.
HOT SPRINGS, NC 28743 US
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Contact DAGMAR MASER
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Regulation Number 876.5130

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Classification Product Code FGI
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Date Received 09/11/2002
Decision Date 12/10/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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