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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
Predetermined Change
Control Plan Authorized		 No
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