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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 K970541
Device Name AESCULAP MODULAR MONOPOLAR ELECTRODES
Applicant
Aesculap, Inc.
1000 Gateway Blvd.
South San Francisco,  CA  94080
Applicant Contact MARY ELLEN HOLDEN
Correspondent
Aesculap, Inc.
1000 Gateway Blvd.
South San Francisco,  CA  94080
Correspondent Contact MARY ELLEN HOLDEN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/12/1997
Decision Date 03/28/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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