FDA 510(k) Application Details - K043021

Device Classification Name Ureteroscope And Accessories, Flexible/Rigid

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510(K) Number K043021
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
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Regulation Number 876.1500

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Classification Product Code FGB
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Date Received 11/03/2004
Decision Date 03/16/2005
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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