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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 K924732
Device Name PORTA PLUMESAFE(TM) 601 SMOKE EVACUATION SYSTEM
Applicant
Buffalo Filter Co., Inc.
8388 Bridlewood Dr.
E. Amherst,  NY  14051
Applicant Contact CLINTON R HOLLAND
Correspondent
Buffalo Filter Co., Inc.
8388 Bridlewood Dr.
E. Amherst,  NY  14051
Correspondent Contact CLINTON R HOLLAND
Regulation Number878.5070
Classification Product Code
FYD  
Date Received09/22/1992
Decision Date 09/13/1993
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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