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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tent, oxygen, electrically powered
510(k) Number K882817
Device Name LUNG DIFFUSION GAS MIXTURE
Applicant
SWISCO, INC.
P.O. BOX 1563
LAKE CHARLES,  LA  70602
Applicant Contact LEE PHILLIPS
Correspondent
SWISCO, INC.
P.O. BOX 1563
LAKE CHARLES,  LA  70602
Correspondent Contact LEE PHILLIPS
Regulation Number868.5710
Classification Product Code
BYK  
Date Received07/08/1988
Decision Date 08/15/1988
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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