FDA 510(k) Application Details - K141250

Device Classification Name Ureteroscope And Accessories, Flexible/Rigid

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510(K) Number K141250
Device Name Ureteroscope And Accessories, Flexible/Rigid
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC.
2151 E. GRAND AVENUE
EL SEGUNDO, CA 90245 US
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Contact LEIGH SPOTTEN
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Regulation Number 876.1500

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Classification Product Code FGB
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Date Received 05/14/2014
Decision Date 06/11/2014
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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