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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, continuous, facility use
510(k) Number K081743
Device Name CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS
Applicant
DRAEGER MEDICAL AG & CO. KG
53/55 MOISLINGER ALLEE
LUEBECK,  DE 23542
Applicant Contact KARIN LUEBBERS
Correspondent
DRAEGER MEDICAL AG & CO. KG
53/55 MOISLINGER ALLEE
LUEBECK,  DE 23542
Correspondent Contact KARIN LUEBBERS
Regulation Number868.5895
Classification Product Code
CBK  
Date Received06/19/2008
Decision Date 09/22/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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