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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resuscitator, Manual, Non Self-Inflating
510(k) Number K092687
Device Name VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER
Applicant
A Plus Medical
5431 Avenida Encinas
Suite G
Carlsbad,  CA  92008
Applicant Contact THOMAS LOESCHER
Correspondent
A Plus Medical
5431 Avenida Encinas
Suite G
Carlsbad,  CA  92008
Correspondent Contact THOMAS LOESCHER
Regulation Number868.5905
Classification Product Code
NHK  
Date Received09/01/2009
Decision Date 11/23/2009
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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