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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 K894038
Device Name PLUME-AWAY SMOKE EVACUATION SYSTEM
Applicant
Laser Technologies Group, Inc.
6550 York Ave. S.
Suite 412
Edina,  MN  55435
Applicant Contact DONALD HEWITT
Correspondent
Laser Technologies Group, Inc.
6550 York Ave. S.
Suite 412
Edina,  MN  55435
Correspondent Contact DONALD HEWITT
Regulation Number878.5070
Classification Product Code
FYD  
Date Received06/06/1989
Decision Date 09/28/1989
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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