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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
Predetermined Change
Control Plan Authorized		 No
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