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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 K894850
Device Name 8053 TWO STAGE TYPE A-B NITROUS OXIDE THERAPY CYLI
Applicant
MODERN ENGINEERING CO., INC.
P.O. BOX 31725
ST. LOUIS,  MO  63131
Applicant Contact JAMES F FAUSEK
Correspondent
MODERN ENGINEERING CO., INC.
P.O. BOX 31725
ST. LOUIS,  MO  63131
Correspondent Contact JAMES F FAUSEK
Regulation Number868.2700
Classification Product Code
CAN  
Date Received07/31/1989
Decision Date 08/31/1989
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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