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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 K940720
Device Name BUSSE ISOLATION AND PROCEDURAL MASKS
Applicant
BUSSE HOSPITAL DISPOSABLES, INC.
75 ARKAY DR.
HAUPPAUGE,  NY  11788
Applicant Contact EILEEN RAMA
Correspondent
BUSSE HOSPITAL DISPOSABLES, INC.
75 ARKAY DR.
HAUPPAUGE,  NY  11788
Correspondent Contact EILEEN RAMA
Regulation Number878.4040
Classification Product Code
FXX  
Date Received02/18/1994
Decision Date 11/02/1994
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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