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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 K131402
Device Name VISICLEAR SMOKE EVACUATION SYSTEM
Applicant
Buffalo Filter Co., Inc.
5900 Genesee St.
Lancaster,  NY  14086
Applicant Contact CARRIE TERMIN
Correspondent
Buffalo Filter Co., Inc.
5900 Genesee St.
Lancaster,  NY  14086
Correspondent Contact CARRIE TERMIN
Regulation Number878.5070
Classification Product Code
FYD  
Date Received05/15/2013
Decision Date 03/03/2014
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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