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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Regulator, Pressure, Gas Cylinder
510(k) Number K894302
Device Name OXYGEN THERAPY REGULATOR
Applicant
MODERN ENGINEERING CO., INC.
P.O. BOX 31725
ST. LOUIS,  MO  63131
Applicant Contact JAMES FAUSEK
Correspondent
MODERN ENGINEERING CO., INC.
P.O. BOX 31725
ST. LOUIS,  MO  63131
Correspondent Contact JAMES FAUSEK
Regulation Number868.2700
Classification Product Code
CAN  
Date Received05/03/1989
Decision Date 08/07/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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