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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 K022934
Device Name SILENTFLOW 2 EXHALATION SYSTEM, MODEL WM 23650
Applicant
Gottlieb Weinmann Geraete Fuer Medizin Und Arbeits
Kronsaalsweg 40
Hamburg,  DE 22525
Applicant Contact ECKHARDT ALBERS
Correspondent
Gottlieb Weinmann Geraete Fuer Medizin Und Arbeits
Kronsaalsweg 40
Hamburg,  DE 22525
Correspondent Contact ECKHARDT ALBERS
Regulation Number868.5905
Classification Product Code
BZD  
Date Received09/04/2002
Decision Date 11/14/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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