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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 K032596
Device Name STURDY MANUAL RESUSCITATOR
Applicant
STURDY INDUSTRIAL CO., LTD
6833 SAINT LAWRENCE STREET
PLANO,  TX  75024
Applicant Contact ERIC LUO
Correspondent
STURDY INDUSTRIAL CO., LTD
6833 SAINT LAWRENCE STREET
PLANO,  TX  75024
Correspondent Contact ERIC LUO
Regulation Number868.5915
Classification Product Code
BTM  
Date Received08/22/2003
Decision Date 08/05/2004
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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