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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 K852935
Device Name ESCHMANN ELECTROSURGICAL UNIT, MODEL TD411
Applicant
Eschmann Bros. & Walsh , Ltd.
Peter Rd., Lancing
Sussex Bn15 8tj,  GB
Applicant Contact V. J COOPER
Correspondent
Eschmann Bros. & Walsh , Ltd.
Peter Rd., Lancing
Sussex Bn15 8tj,  GB
Correspondent Contact V. J COOPER
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/10/1985
Decision Date 10/10/1985
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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