FDA 510(k) Application Details - K952574

Device Classification Name Resectoscope

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510(K) Number K952574
Device Name Resectoscope
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE
CULVER CITY, CA US
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Contact BETTY M JOHNSON
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Regulation Number 876.1500

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Classification Product Code FJL
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Date Received 06/05/1995
Decision Date 07/20/1995
Decision SE - Substantially Equivalent
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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