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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Nephroscope
510(k) Number K950433
Device Name KARL STORZ ENDOPYELOTOMY SET FOR ENDOSCOPIC UROLOGY PROCEDURES
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE
CULVER CITY,  CA  90230 -7600
Applicant Contact BETTY M JOHNSON
Correspondent
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE
CULVER CITY,  CA  90230 -7600
Correspondent Contact BETTY M JOHNSON
Regulation Number876.1500
Classification Product Code
FGA  
Date Received02/02/1995
Decision Date 03/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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