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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 K911471
Device Name LUNG DIFFUSION GAS MIXTURES
Applicant
Norco, Inc.
1121 W. Amity
Boise,  ID  83705
Applicant Contact LYLE R FEELY
Correspondent
Norco, Inc.
1121 W. Amity
Boise,  ID  83705
Correspondent Contact LYLE R FEELY
Regulation Number868.6400
Classification Product Code
BXK  
Date Received04/03/1991
Decision Date 06/18/1991
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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