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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valve, Non-Rebreathing
510(k) Number K883383
Device Name LIFEGUARD VENT MASK
Applicant
Breath of Life, Inc.
P.O. Box 7144
Flushing,  NY  11355
Applicant Contact SIMPSON GRAY
Correspondent
Breath of Life, Inc.
P.O. Box 7144
Flushing,  NY  11355
Correspondent Contact SIMPSON GRAY
Regulation Number868.5870
Classification Product Code
CBP  
Date Received08/09/1988
Decision Date 11/21/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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