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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, emergency, powered (resuscitator)
510(k) Number K112783
Device Name MANUJET III
Applicant
VBM MEDIZINTECHNIK GMBH
1, EINSTEINSTRASSE
SULZ AM NECKAR,
BADEN-WURTTEMBERG,  DE 72172
Applicant Contact ANKE BLOCHER
Correspondent
VBM MEDIZINTECHNIK GMBH
1, EINSTEINSTRASSE
SULZ AM NECKAR,
BADEN-WURTTEMBERG,  DE 72172
Correspondent Contact ANKE BLOCHER
Regulation Number868.5925
Classification Product Code
BTL  
Date Received09/26/2011
Decision Date 12/22/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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