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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K944823
Device Name KARL STORZ INSULATED DISSECTING CANNULAE, CANNULAE, SUCTION TUBES, INSERT TUBES
Applicant
Karl Storz Endoskop GmbH
600 Corporate Pt.e
Culver City,  CA  90230
Applicant Contact BETTY M JOHNSON
Correspondent
Karl Storz Endoskop GmbH
600 Corporate Pt.e
Culver City,  CA  90230
Correspondent Contact BETTY M JOHNSON
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/29/1994
Decision Date 11/02/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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