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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resectoscope
510(k) Number K934647
Device Name KARL STORZ CUTTING LOOP ELECTRODES MODIFICATION
Applicant
Karl Storz Endoscopy-America, Inc.
10111 W. Jefferson Blvd.
Culver City,  CA  90232 -3578
Applicant Contact ROBERT R GIORGINI
Correspondent
Karl Storz Endoscopy-America, Inc.
10111 W. Jefferson Blvd.
Culver City,  CA  90232 -3578
Correspondent Contact ROBERT R GIORGINI
Regulation Number876.1500
Classification Product Code
FJL  
Date Received09/29/1993
Decision Date 02/09/1994
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
Recalls CDRH Recalls
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