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FDA 510(k) Application Details - K031278
Device Classification Name
Ureteroscope And Accessories, Flexible/Rigid
More FDA Info for this Device
510(K) Number
K031278
Device Name
Ureteroscope And Accessories, Flexible/Rigid
Applicant
Stryker Endoscopy
5900 OPTICAL CT.
SAN JOSE, CA 95138 US
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Contact
CHRISTOPHER L COOK
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
FGB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/22/2003
Decision Date
10/16/2003
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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