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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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