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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 K972269
Device Name DISPOSABLE PATIENT RETURN ELECTRODE
Applicant
Erbe USA, Inc.
1070 Thornwood Ln.
Dacula,  GA  30211
Applicant Contact MICHAEL A CLARK
Correspondent
Erbe USA, Inc.
1070 Thornwood Ln.
Dacula,  GA  30211
Correspondent Contact MICHAEL A CLARK
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/17/1997
Decision Date 07/09/1997
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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