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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 K934985
Device Name ENDOSCOPIC HIGH FREQUENCY MONOPOLAR CORD
Applicant
KARL STORZ Endoscopy-America, Inc.
10111 W. Jefferson Blvd.
Culver City,  CA  90232
Applicant Contact ROBERT R GIORGINI
Correspondent
KARL STORZ Endoscopy-America, Inc.
10111 W. Jefferson Blvd.
Culver City,  CA  90232
Correspondent Contact ROBERT R GIORGINI
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/18/1993
Decision Date 02/17/1994
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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