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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 K913501
Device Name TRACHEOSTOMY MASK
Applicant
B & F MEDICAL PRODUCTS, INC.
1421 N. EXPRESSWAY DR.
toledo,  OH  43608
Applicant Contact jim spillis
Correspondent
B & F MEDICAL PRODUCTS, INC.
1421 N. EXPRESSWAY DR.
toledo,  OH  43608
Correspondent Contact jim spillis
Regulation Number868.5580
Classification Product Code
BYG  
Date Received08/07/1991
Decision Date 01/13/1992
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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