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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 K030864
Device Name VADI MANUAL RESUSCITATOR
Applicant
VEDI CORP.
6833 SAINT LAWRENCE ST.
PLANO,  TX  75024
Applicant Contact ERIC LUO
Correspondent
VEDI CORP.
6833 SAINT LAWRENCE ST.
PLANO,  TX  75024
Correspondent Contact ERIC LUO
Regulation Number868.5915
Classification Product Code
BTM  
Date Received03/18/2003
Decision Date 01/30/2004
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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