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FDA 510(k) Application Details - K033754
Device Classification Name
Endoscopic Guidewire, Gastroenterology-Urology
More FDA Info for this Device
510(K) Number
K033754
Device Name
Endoscopic Guidewire, Gastroenterology-Urology
Applicant
WILSON-COOK MEDICAL, INC.
4900 BETHANIA STATION RD.
WINSTON-SALEM, NC 27105 US
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Contact
MARGE WALLS-WALKER
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
OCY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/01/2003
Decision Date
12/30/2003
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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