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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas, Calibration (Specified Concentration)
510(k) Number K924796
Device Name LUNG DIFFUSION GAS MIXTURE
Applicant
Gulf States Airgas
5480 Hamilton Blvd.,
P.O. Box 190969
Theodore,  AL  36582
Applicant Contact WADE HOLT
Correspondent
Gulf States Airgas
5480 Hamilton Blvd.,
P.O. Box 190969
Theodore,  AL  36582
Correspondent Contact WADE HOLT
Regulation Number868.6400
Classification Product Code
BXK  
Date Received09/23/1992
Decision Date 12/17/1992
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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