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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name syringe, balloon inflation
510(k) Number K082755
Device Name SEDAT FLAMINGO
Applicant
SEDAT
8895 TOWNE CENTRE DRIVE
105-416
SAN DIEGO,  CA  92122
Applicant Contact CHARLES COUSIN
Correspondent
SEDAT
8895 TOWNE CENTRE DRIVE
105-416
SAN DIEGO,  CA  92122
Correspondent Contact CHARLES COUSIN
Regulation Number870.1650
Classification Product Code
MAV  
Date Received09/19/2008
Decision Date 12/15/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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