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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name conserver, oxygen
510(k) Number K023420
Device Name PULSED OXYGEN CONSERVING DEVICE - EVERY BREATH, POCDEB, REACTEB
Applicant
MEDICAL ELECTRONIC DEVICES, INC.
2807 OREGON CT. #D6
TORRANCE,  CA  90503
Applicant Contact THOMAS WENZEL
Correspondent
MEDICAL ELECTRONIC DEVICES, INC.
2807 OREGON CT. #D6
TORRANCE,  CA  90503
Correspondent Contact THOMAS WENZEL
Regulation Number868.5905
Classification Product Code
NFB  
Date Received10/11/2002
Decision Date 10/25/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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