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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Catheter, G-U
510(k) Number K951995
Device Name KARL STORZ CATHETERS, MANDRIN, PLUGS, CONNECTOR
Applicant
Karl Storz Endoskop GmbH
600 Corporate Pt.e
Culver City,  CA  90230
Applicant Contact JUDITH K MURPHY
Correspondent
Karl Storz Endoskop GmbH
600 Corporate Pt.e
Culver City,  CA  90230
Correspondent Contact JUDITH K MURPHY
Regulation Number876.5130
Classification Product Code
KNY  
Date Received04/28/1995
Decision Date 05/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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