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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 K790166
Device Name OXYGEN MASK, ADULT VINYL
Applicant
AIRLIFE, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
AIRLIFE, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5580
Classification Product Code
BYG  
Date Received01/12/1979
Decision Date 03/16/1979
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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