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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 K970352
Device Name SMARTVAC SMOKE EVACUATION SYSTEM
Applicant
Isomedix Operations, Inc.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact MARY MCNAMARA-CULLINANE, RAC
Correspondent
Isomedix Operations, Inc.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact MARY MCNAMARA-CULLINANE, RAC
Regulation Number878.5070
Classification Product Code
FYD  
Date Received01/30/1997
Decision Date 11/04/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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