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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystoscope And Accessories, Flexible/Rigid
510(k) Number K935278
Device Name KARL STORZ FIXED MAGNIFICATION TELESCOPE/KARL STORZ VARIABLE MAGNIFICATION TELESCOPE
Applicant
Karl Storz Endoscopy-America, Inc.
600 Corporate Pointe
Culver City,  CA  90230 -7600
Applicant Contact SUSIE S CHEN
Correspondent
Karl Storz Endoscopy-America, Inc.
600 Corporate Pointe
Culver City,  CA  90230 -7600
Correspondent Contact SUSIE S CHEN
Regulation Number876.1500
Classification Product Code
FAJ  
Date Received11/03/1993
Decision Date 06/24/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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