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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, Powered (Resuscitator)
510(k) Number K140707
Device Name LIFEBORNE INFANT RESUSCITATOR
Applicant
International Biomedical
8206 Cross Park Dr.
Austin,  TX  78754
Applicant Contact AMY PIEPER
Correspondent
International Biomedical
8206 Cross Park Dr.
Austin,  TX  78754
Correspondent Contact AMY PIEPER
Regulation Number868.5925
Classification Product Code
BTL  
Date Received03/20/2014
Decision Date 05/28/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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