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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Pulmonary Function Data
510(k) Number K942864
Device Name LUNG DIFFUSION
Applicant
Nordan Smith Welding Supplies
5051 Hwy. 42
P.O. Box 107
Hattiesburg,  MS  39403
Applicant Contact WILLIAM DOWDEN
Correspondent
Nordan Smith Welding Supplies
5051 Hwy. 42
P.O. Box 107
Hattiesburg,  MS  39403
Correspondent Contact WILLIAM DOWDEN
Regulation Number868.1880
Classification Product Code
BZC  
Date Received06/17/1994
Decision Date 03/03/1995
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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