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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 K963189
Device Name ERBE APC 300 ARGON PLASMA COAGULATOR AND ACCESSORIES - ARGON PLASMA COAGULATOR AND ACCESSORIES
Applicant
Erbe USA, Inc.
55 Northern Blvd., Suite 410
Great Neck,,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
Erbe USA, Inc.
55 Northern Blvd., Suite 410
Great Neck,,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/14/1996
Decision Date 11/26/1996
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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