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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
Predetermined Change
Control Plan Authorized		 No
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