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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name airway, oropharyngeal, anesthesiology
510(k) Number K861054
Device Name DISPOSABLE RESCUE BREATHING DEVICE
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 Number868.5110
Classification Product Code
CAE  
Date Received03/19/1986
Decision Date 04/09/1986
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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