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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 K983298
Device Name BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO FILTER VIROSAFE ERBIUM:YAG PREFILTER - #BFEYAG04PF
Applicant
BUFFALO FILTER CO., INC.
6000 N. BAILEY AVE, SUITE 9
BUFFALO,  NY  14226
Applicant Contact CLINTON R HOLLAND JR.
Correspondent
BUFFALO FILTER CO., INC.
6000 N. BAILEY AVE, SUITE 9
BUFFALO,  NY  14226
Correspondent Contact CLINTON R HOLLAND JR.
Regulation Number878.5070
Classification Product Code
FYD  
Date Received09/21/1998
Decision Date 08/16/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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