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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 K021442
Device Name OEMEDIC INTERNATIONAL INC. BESMED SINGLE USE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK & 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 07/30/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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