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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 K881483
Device Name AIRWAY-CIRCULATION EVALUATOR
Applicant
Resuscitation Ace, Inc.
3965 Pinehurst Circle
Denver,  CO  80235
Applicant Contact CHARLES M ABERNATHY
Correspondent
Resuscitation Ace, Inc.
3965 Pinehurst Circle
Denver,  CO  80235
Correspondent Contact CHARLES M ABERNATHY
Regulation Number868.5915
Classification Product Code
BTM  
Date Received04/08/1988
Decision Date 12/16/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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