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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 K935309
Device Name LUNG DIFFUSION
Applicant
Acetylene Gas Co.
3500 Bernard
St. Louis,  MO  63103
Applicant Contact KRIS LUTHER
Correspondent
Acetylene Gas Co.
3500 Bernard
St. Louis,  MO  63103
Correspondent Contact KRIS LUTHER
Regulation Number868.1880
Classification Product Code
BZC  
Date Received11/02/1993
Decision Date 09/27/1994
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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