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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 K142335
Device Name RapidVac Smoke Evacuator System
Applicant
Covidien
15 Hampshire St.
Mansfield,  MA  02048
Applicant Contact JOSE MARQUEZ
Correspondent
Covidien
15 Hampshire St.
Mansfield,  MA  02048
Correspondent Contact JOSE MARQUEZ
Regulation Number878.5070
Classification Product Code
FYD  
Date Received08/21/2014
Decision Date 01/14/2015
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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