FDA 510(k) Application Details - K000767

Device Classification Name Accessories, Catheter, G-U

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510(K) Number K000767
Device Name Accessories, Catheter, G-U
Applicant MEMCATH TECHNOLOGIES LLC.
1777 OAKDALE AVE.
WEST ST. PAUL, MN 55118-4031 US
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Contact MARC JAKER
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Regulation Number 876.5130

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Classification Product Code KNY
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Date Received 03/09/2000
Decision Date 06/05/2000
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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