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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 K873586
Device Name LUNG DIFFUSION GAS
Applicant
NATIONAL WELDERS
P.O. BOX 31007
CHARLOTTE,  NC  28231
Applicant Contact TED W YANKUSH
Correspondent
NATIONAL WELDERS
P.O. BOX 31007
CHARLOTTE,  NC  28231
Correspondent Contact TED W YANKUSH
Regulation Number868.6400
Classification Product Code
BXK  
Date Received09/04/1987
Decision Date 02/12/1988
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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