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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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More FDA Info for this Product Code
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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