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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 K882210
Device Name MEDIBLEND (TM) LUNG DIFFUSION GAS MIXTURES
Applicant
Linde Div. Union Carbide Corp.
P.O. Box 6744,
200 Cottontail Ln.
Somerset,  NJ  08875
Applicant Contact SUZANNE G FIORINO
Correspondent
Linde Div. Union Carbide Corp.
P.O. Box 6744,
200 Cottontail Ln.
Somerset,  NJ  08875
Correspondent Contact SUZANNE G FIORINO
Regulation Number868.6400
Classification Product Code
BXK  
Date Received05/26/1988
Decision Date 06/21/1988
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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