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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name transducer, blood-pressure, extravascular
510(k) Number K102033
Device Name COMBITRANS MONITORING SETS AND ACCESSORIES
Applicant
B. BRAUN MELSUNGEN AG
901 MARCON BLVD
ALLENTOWN,  PA  18109
Applicant Contact LISA GIAQUINTO
Correspondent
B. BRAUN MELSUNGEN AG
901 MARCON BLVD
ALLENTOWN,  PA  18109
Correspondent Contact LISA GIAQUINTO
Regulation Number870.2850
Classification Product Code
DRS  
Date Received07/19/2010
Decision Date 04/07/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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