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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 K013738
Device Name WEINMANN SOMNOMASK
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 Received11/13/2001
Decision Date 01/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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