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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name attachment, breathing, positive end expiratory pressure
510(k) Number K092029
Device Name VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310
Applicant
DRAEGER MEDICAL AG & CO. KG
3135 Quarry Road
Telford,  PA  18969
Applicant Contact JOYCE KILROY
Correspondent
DRAEGER MEDICAL AG & CO. KG
3135 Quarry Road
Telford,  PA  18969
Correspondent Contact JOYCE KILROY
Regulation Number868.5965
Classification Product Code
BYE  
Date Received07/06/2009
Decision Date 08/06/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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