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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 K094003
Device Name REVIVATOR
Applicant
HERSILL, S.L.
PUERTO DE NAVACERRADA, 3
MOSTOLES ( MADRID),  ES 28935
Applicant Contact ANA MARIA ROMERO
Correspondent
HERSILL, S.L.
PUERTO DE NAVACERRADA, 3
MOSTOLES ( MADRID),  ES 28935
Correspondent Contact ANA MARIA ROMERO
Regulation Number868.5915
Classification Product Code
BTM  
Date Received12/28/2009
Decision Date 09/17/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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