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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mask, oxygen
510(k) Number K772141
Device Name AEROSOL & OXYGEN MASKS
Applicant
B & F MEDICAL PRODUCTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
B & F MEDICAL PRODUCTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5580
Classification Product Code
BYG  
Date Received11/14/1977
Decision Date 01/03/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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