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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K930067
Device Name BUFFALO FILTER SURGICAL MASK
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 Number878.4040
Classification Product Code
FXX  
Date Received01/06/1993
Decision Date 11/30/1993
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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