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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ventilator, non-continuous (respirator)
510(k) Number K073673
Device Name SOYALA FULL FACE MASK GEL VENTED
Applicant
WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG
KRONSAALSWEG 40
HAMBURG,  DE 22525
Applicant Contact RALF EGENOLF
Correspondent
WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG
KRONSAALSWEG 40
HAMBURG,  DE 22525
Correspondent Contact RALF EGENOLF
Regulation Number868.5905
Classification Product Code
BZD  
Date Received12/27/2007
Decision Date 03/28/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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