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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Exhaust, Surgical
510(k) Number K940266
Device Name BEI MEDICAL SYSTEMS' SMOKE EVACUATOR
Applicant
Bei Medical Systems Co., Inc.
83 Hobart St.
Hackensack,  NJ  07601
Applicant Contact H. PHILIP HOVNANIAN, PH.D., P.E.
Correspondent
Bei Medical Systems Co., Inc.
83 Hobart St.
Hackensack,  NJ  07601
Correspondent Contact H. PHILIP HOVNANIAN, PH.D., P.E.
Regulation Number878.5070
Classification Product Code
FYD  
Date Received01/21/1994
Decision Date 03/24/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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