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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 K935815
Device Name ERBOTOM ICC 50
Applicant
Erbe USA, Inc.
775 Oxford Hall Dr.
Lawrenceville,  GA  30244
Applicant Contact MICHAEL A CLARK
Correspondent
Erbe USA, Inc.
775 Oxford Hall Dr.
Lawrenceville,  GA  30244
Correspondent Contact MICHAEL A CLARK
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/02/1993
Decision Date 03/31/1994
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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