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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 K071080
Device Name ELECTROSURGICAL INFANT PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD, MODEL EP 211M
Applicant
E Surgical, LLC
1910 N. California Blvd.
Suite 1040
Walnut Creek,  CA  94596
Applicant Contact HANS J RICHTER
Correspondent
E Surgical, LLC
1910 N. California Blvd.
Suite 1040
Walnut Creek,  CA  94596
Correspondent Contact HANS J RICHTER
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/17/2007
Decision Date 08/31/2007
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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