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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 K950663
Device Name BEI MEDICAL SYSTEMS MG-1000HS MONOPOLAR GENERATOR
Applicant
Bei Medical Systems Co., Inc.
83 Hobart St.
Hackensack,  NJ  07601
Applicant Contact H. P HOVNANIAN
Correspondent
Bei Medical Systems Co., Inc.
83 Hobart St.
Hackensack,  NJ  07601
Correspondent Contact H. P HOVNANIAN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/13/1995
Decision Date 05/17/1995
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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