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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 K943226
Device Name BUFFALO FILTER REPLACEMENT FILTER #BSPF030
Applicant
BUFFALO FILTER CO., INC.
6000 NORTH BAILEY AVENUE,
SUITE 9
BUFFALO,  NY  14226
Applicant Contact CLINTON R HOLLAND
Correspondent
BUFFALO FILTER CO., INC.
6000 NORTH BAILEY AVENUE,
SUITE 9
BUFFALO,  NY  14226
Correspondent Contact CLINTON R HOLLAND
Regulation Number878.5070
Classification Product Code
FYD  
Date Received07/06/1994
Decision Date 07/10/1995
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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