FDA 510(k) Application Details - K050304

Device Classification Name Endoscopic Guidewire, Gastroenterology-Urology

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510(K) Number K050304
Device Name Endoscopic Guidewire, Gastroenterology-Urology
Applicant CONMED CORP.
129 CONCORD ROAD
BUILDING 3
BILLERICA, MA 01821 US
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Contact THOMAS HIRTE
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Regulation Number 876.1500

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Classification Product Code OCY
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Date Received 02/08/2005
Decision Date 03/08/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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