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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ventilator, emergency, manual (resuscitator)
510(k) Number K021446
Device Name OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK AND RESERVOIR
Applicant
OEMEDIC INTERNATIONAL, INC.
13 RED FOX LN.
LITTLETON,  CO  80127
Applicant Contact Kevin Walls
Correspondent
OEMEDIC INTERNATIONAL, INC.
13 RED FOX LN.
LITTLETON,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number868.5915
Classification Product Code
BTM  
Date Received05/06/2002
Decision Date 10/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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